Precision Medical PM4130 EasyPulse POC3 - Manual (Page 19)

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Portable Oxygen Concentrator
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
PM4130
Classification: IIa
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, EN ISO 14971, EN 60601‑1, EN 60601‑1‑2, EN 60601‑1‑8,
EN 62366, EN ISO 3744, ISO 80601‑2‑67, ISO 80601‑2‑69,
EN ISO 15001, ISO 13485, ISO 15223‑1, 2006/66/EC,
2011/65/EC (RoHS 2)
Notified Body: AMTAC Certification Services Limited
0473
Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK
Certification Registration No’s: 1126 A CE
Date of Expiry: 26 July 2017
Devices already manufactured: S/N traceability Device History Records
Validity of DOC: 31 August 2012 to Date of Expiry
Manufacture Representative: Quality Manager
Position:
Quality Systems/ISO Representative
Date of Issue: 31 August 2012
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