DECLARATION OF CONFORMITY
Manufacturer: | Precision Medical, Inc. |
| 300 Held Drive, Northampton, PA 18067, USA |
| CONTACT: Quality Manager |
| Phone: |
Authorized European Representative: | Emergo Europe |
| molenstraat 15 |
| 2513 BH, The Hague |
| The Netherlands |
Product: | Gas Mixers for Medical Use |
Model(s): | PM5200EN, PM5200MEN, PM5300EN, PM5300MEN |
MDD Class: | IIb |
Classification criteria: | Clause 3.1 Rule 11 of Annex IX of MDD |
As delivered, the object of the declaration described above is in conformity with the requirements of MDD 93/42/EEC Annex II.3 and the following documents:
Document | Title | Edition | ||
ISO 14971 | Medical Devices - Application of Risk Management 2000+A1:2003 | |||
| to Medical Devices |
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EN 980 | Graphical Symbols for Use in the Labeling of Medical | 2003 | ||
| Devices |
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EN 1041 | Information supplied by the Manufacturer with Medical | 1998 | ||
| Devices |
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ISO 11195 | Gas mixers for medical use - stand alone gas mixers | 1995 | ||
ISO 15001 | Anesthetic and respiratory equipment | 2004 | ||
| with oxygen |
| ||
Notified Body: | TÜV Rheinland Products Safety GmbH |
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EC Certificate No.: HD600119110 0001
www.precisionmedical.com
ISO 13485 Certified
504745 Rev8 (E) 03/18/08 (?M) Printed in USA