Declaration Of Conformity - DeVilbiss Healthcare DV55 Bilevel Série Mode D'emploi

EN

DEclaration of conformity

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:
Notified Body:
MDD:
Safety Standards Applied:
EMC Compliance To:
Authorized Representative: Sunrise Medical Ltd.
®Registered U.S. Patent and Trademark Office and other countries.
0044
SE-DV56
32
DeVilbiss Healthcare
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP
DeVilbiss IntelliPAP ™ or SleepCube™ DV5x Series CPAP
®
Models DV55 Bilevel S and DV56 Bilevel ST
IIa, Rule 9
ISO13485:2003
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
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688