Declaration Of Conformity - DeVilbiss DV5HH Manual De Usuario

EN

DECLARATION OF CONFORMITY

Manufacturer:
Address:
Product Designation:
Type, Model:
We herewith declare that the above-mentioned product complies with the requirements of EC Directive 93/42/EEC and the following:
Class:
Quality System Standards Applied: ISO13485:2003
Notified Body:
MDD:
Safety Standards Applied:
EMC Compliance To:
Authorized Representative:
®Registered U.S. Patent and Trademark Office and other countries.
0044
10 A-DV5HH
DeVilbiss Healthcare LLC DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, PA 15501-2125 USA
CPAP
DeVilbiss® IntelliPAP™ or SleepCube™DV5x Series CPAP Models DV51 Standard CPAP and DV54 AutoAdjust
and DeVilbiss Heated Humidifier Model DV5HH
IIa, Rule 2
TÜV NORD
Annex II Applied
IEC 60601-1:1988 + A1 1995
IEC 60601-1-4:2000
ISO 14971:2000
EN ISO17510:2002.
IEC 60601-1-2:2001
DeVilbiss Healthcare GmbH
Kamenzer Straße 3
68309 Mannheim
Germany
+49-621-178-98-230
Fax: +49-621-178-98-220
DeClArATion oF ConFormiTy