| DECLARATION OF CONFORMITY |
Manufacturer: | Precision Medical, Inc. |
| 300 Held Drive, Northampton, PA 18067, USA |
| CONTACT: Quality Manager |
| Phone: |
Authorized European Representative: Emergo Europe (European Office)
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
| Fax: +31 (0) 70.346.7299 |
Product: | Gas Mixers for Medical Use (Blender) |
Model(s): | PM5470EN, PM5480EN, PM5570EN, PM5580EN |
MDD Class: | IIb |
Classification criteria: | Clause 3.2 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 | Edition | |
EN 980 | 2008 |
|
EN 1041 | 2008 |
|
ISO 11198 | 1995 |
|
ISO 14971 | 2007 2nd Ed | |
ISO 15001 | 2004 |
|
ISO 7000 | 2004 |
|
Notified Body: | TÜV Rheinland Products Safety GmbH | |
EC Certificate No.: HD60019110 0001
www.precisionmedical.com
ISO 13485 Certified
505963 Rev3 (E) 04/05/10 Printed in USA