Given Imaging CAPDH-2 Endoscopy Capsule User Manual Compliance Statement

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Document ID	3276425
Application ID	GnPoB5K2MJhpjuIMRYAHkA==
Document Description	Compliance Statement
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	10.94kB (136740 bits)
Date Submitted	2017-02-05 00:00:00
Date Available	2017-02-08 00:00:00
Creation Date	2017-01-31 13:29:56
Producing Software	Acrobat Distiller 11.0 (Windows)
Document Lastmod	2017-01-31 13:29:56
Document Title	Microsoft Word - Draft WW RF Compliance Datasheet-Colon 2 .docx
Document Creator	PScript5.dll Version 5.2.2
Document Author:	gavidj1

World Wide Radio Communication R egulations
World Wide Radio Compliance, the product is in compliance with applicable regulations and standards.
Brand: Pillcam ™
Model : Colon 2
United States Compliance
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
FCC ID:O8PCAPDH‐2
Brazil Compliance
European Compliance
Spanish
French
This equipment operates on a secondary basis and, consequently, must accept
harmful interference, including from stations of the same kind, and may not
cause harmful interference to systems operating on a primary basis.
IMPORTANT: Changes or modifications to this product
not authorized by Medtronic, Inc., could void the FCC
Certification and negate your authority to operate this
product.
Este equipamento opera em caráter secundário isto é, não tem direito à proteção
contra interferência prejudicial, mesmo de estações do mesmo tipo, e não pode causar
interferência a sistemas operando em caráter primário.
Hereby, Medtronic declares that this Radio Equipment Model number Colon 2 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:
www.MedtronicCompliance.eu.
Por la presente, Medtronic declara que este equipo de radio, modelo número Colon 2 cumple la Directiva 2014/53/EU. El texto completo de la Declaración de Conformidad CE está disponible en la siguiente dirección de
internet: www.MedtronicCompliance.eu.
Par la présente, Medtronic déclare que cet équipement radio Modèle Colon 2 est conforme à la directive 2014/53/UE. Le texte intégral de la déclaration de conformité de l'UE est disponible sur le site Internet:
www.MedtronicCompliance.eu.
Finnish
Medtronic vakuuttaa täten, että tämä radiolaite, mallinumero Colon 2, vastaa direktiiviä 2014/53/EU. EU- vaatimustenmukaisuus- vakuutuksen koko teksti on saatavissa seuraavasta Internet-osoitteesta:
www.MedtronicCompliance.eu.
Estonian
Käesolevaga kinnitab Medtronic, et see raadioseadmestik mudelinumbriga Colon 2 on vastavuses direktiiviga 2014/53/EL. Kogu EL-i vastavusdeklaratsiooni tekst on saadaval järgmisel internetiaadressil:
www.MedtronicCompliance.eu.
Bulgarian
С настоящото Medtronic декларира, че това радиооборудване модел номер Colon 2 е в съответствие с Директива 2014/53/ЕС. Пълният текст на ЕС декларацията за съответствие е на разположение на
следния интернет адрес: www.MedtronicCompliance.eu.
Czech
Společnost Medtronic tímto prohlašuje, že toto radiové zařízení, číslo modelu Colon 2, odpovídá požadavkům směrnice 2014/53/EU. Úplný text EU Prohlášení o shodě je k dispozici na následující internetové adrese:
www.MedtronicCompliance.eu.
Croatian
Ovime tvrtka Medtronic izjavljuje da je ova radijska oprema model Colon 2 skladu s Direktivom 2014/53/EU. Cjelokupan tekst europske izjave o sukladnosti dostupan je na sljedećoj internetskoj stranici:
www.MedtronicCompliance.eu.
EC REP
Manufacturer
Given Imaging, Inc.
15 Hamshire Street,
Mansfield, MA 02048
Authorized Representative in the European
Community Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen, The Netherlands Tel.
RD‐00‐15‐044 Rev A
World Wide Radio Communication R egulations
Hungarian
A Medtronic ezúton nyilatkozza, hogy ez az Colon 2 rádióberendezés megfelel a 2014/53/EU irányelvnek. Az EU megfelelőségi nyilatkozat teljes szövege elérhető a következő internetes címen:
wwwMedtronicCompliance.eu.
Italian
Con il presente documento, Medtronic dichiara che la presente apparecchiatura radio modello Colon 2 è conforme alla direttiva 2014/53/UE. Il testo completo della dichiarazione UE di conformità è disponibile su Internet al
seguente indirizzo: www.MedtronicCompliance.eu.
Šiuo „Medtronic“ deklaruoja, kad šis radijo įrangos modelis, kurio numeris Colon 2, atitinka Direktyvą 2014/53/EB. Visą ES atitikties deklaracijos tekstą galite rasti šiuo interneto adresu: www.MedtronicCompliance.eu.
Lithuanian
Latvian
Ar šo uzņēmums Medtronic apliecina, ka šī radioiekārta, modeļa numurs Colon 2, atbilst Direktīvas 2014/53/ES prasībām. Pilnu ES atbilstības deklarācijas tekstu var skatīt vietnē www.MedtronicCompliance.eu.
Dutch
Hierbij verklaart Medtronic dat deze radioapparatuur modelnummer Colon 2 in overeenstemming is met Richtlijn 2014/53/EU. De volledige tekst van de Europese conformiteitsverklaring is te
vinden op de website: www.MedtronicCompliance.eu.
??
Polish
Firma Medtronic deklaruje niniejszym, że to urządzenie radiowe Colon 2 spełnia wymogi określone w Dyrektywie 2014/53/UE. Pełny tekst deklaracji zgodności UE jest dostępny pod następującym
www.MedtronicCompliance.eu.
Portuguese
Por este meio, a Medtronic declara que este modelo de equipamento de rádio, número Colon 2 está em conformidade com a Diretiva 2014/53/UE. O texto completo da declaração de conformidade da UE está
disponível no seguinte endereço da Internet: www.MedtronicCompliance.eu.
Romanian
Slovak
Slovenian
Swedish
Prin prezenta, Medtronic declară că acest echipament radio număr model Colon 2 este în conformitate cu Directiva 2014/53/UE. Textul complet al declarației de conformitate UE poate fi găsit la următoarea adresă de
internet: www.MedtronicCompliance.eu.
Spoločnosť Medtronic týmto vyhlasuje, že toto rádiové zariadenie, model Colon 2, je v súlade so smernicou 2014/53/EÚ. Úplné znenie vyhlásenia o zhode so smernicami EÚ je k dispozícii na stránke:
www.MedtronicCompliance.eu.
Družba Medtronic izjavlja, da je ta radijska oprema, številka modela Colon 2, v skladu z Direktivo 2014/53/EU. Celotno besedilo izjave EU o skladnosti je na voljo na naslednjem spletnem naslovu:
www.MedtronicCompliance.eu.
Härmed intygar Medtronic att denna radioutrustning med Colon 2 överensstämmer med direktiv 2014/53/EU.
Den fullständiga texten med intyg om överensstämmelse för EU finns
på följande internetadress: www.MedtronicCompliance.eu ..
EC REP
Manufacturer
Given Imaging, Inc.
15 Hamshire Street,
Mansfield, MA 02048
Authorized Representative in the European
Community Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen, The Netherlands Tel.
RD‐00‐15‐044 Rev A

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