Precision-medical Air-Oxygen Blender User Manual download pdf (Page 16)

DECLARATION OF CONFORMITY

 PrecisionMedical,Inc



300HeldDrive

 NorthamptonPA18067,USA

 EmergoEurope(EuropeanOffice)

 Molenstraat15

 2513BH,TheHague

 TheNetherlands

 Phone:+31(0)70.345.8570

 Fax: +31(0)70.346.7299

0473

PM5200EN, PM5200MEN, PM5200NIST, PM5200NISTAP,

PM5300EN, PM5300MEN, PM5300NIST, PM5300NISTAP

Classification: IIb

Classification criteria:

Clause3.2Rule11ofAnnexIXofMDD

Weherebydeclare that anexamination of theundermentioned production quality

assurancesystemhasbeencarriedoutfollowingtherequirementsoftheUKnational

legislationtowhichtheundersignedissubjected,transposingAnnexII,3oftheDirective

93/42/EECandDirective2007/47/EConmedicaldevices.

Wecertifythattheproductionqualitysystemconformstotherelevantprovisionsofthe

aforementionedlegislation,andtheresultentitlestheorganizationtousetheCE0473

markingonthoseproductslistedabove.

Applied Standards:

EN 1041, ISO 11195, EN ISO 13485, EN ISO 14971, EN ISO 15001,

EN ISO 15223-1

Notified Body:



AMTACCertificationServicesLimited

0473

Address: DavyAvenueKnowlhillMiltonKeynesMK58NL,UK

Certification Registration No’s:

1126 CE

 DateofExpiry:03August2017

Devices already manufactured:S/NtraceabilityDeviceHistoryRecords

Validity of DOC: 04August2012toDateofExpiry

Manufacture Representative:

 QualityManager

Position: QualitySystems/ISORepresentative

Date of Issue: 04August2012

Tellushowwearedoing!

Visitusatwww.precisionmedical.com

 504745 Rev1508/09/12Printed in USA

1 2 ... 11 12 13 14 15 16

Comments to this Manuals

No comments

Precision-medical Air-Oxygen Blender User Manual Page 16

Comments to this Manuals

Related products and manuals for Health and hygiene Precision-medical Air-Oxygen Blender