Precision Medical EasyPulse5 Oxygen Conserving Regulator - Manual (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
EasyPulse5 Oxygen Conserving Regulator
198705EN, 195405, 19DE05, 19ES05, 19ES05-EN,19GB05, 19SE05,
19SE05-ES, 198705NG, 195405NG, 19ES05NG, 19ES05NG-EN,
19GB05NG, 19SE05NG, 19SE05NG-NO, 19WM0501
EasyPulse 5+6 Oxygen Conserving Device Series;
198712EN, 195412EN, 19DE12, 19ES12, 19ES12-EN, 19GB12,
19GB12PC, 19SE12, 19SE12-ES, 198712NG, 195412NG,
19ES12NG, 19ES12NG-EN, 19GB12NG, 19SE12NG, 19SE12NG-NO
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: BS 341-3, DIN 477-1, EN 837-1, EN 1041, EN ISO 14971,
EN ISO 15001, ISO 228-1, ISO 10524-1, ISO 10524-3,
ISO 15223-1, ISO 18779, SS 367615
Notified Body:
AMTAC Certification Services Limited
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
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504429 Rev12 6/15 (?M) Printed in USA