Declaration Of Conformity - DeVilbiss Healthcare SleepCube DV54 AutoAdjust Guide D'instructions

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
Sunrise Medical dba DeVilbiss Healthcare
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP
DeVilbiss® IntelliPAP™ or SleepCube™DV5x Series CPAP
Model DV54 AutoAdjust
IIa, Rule 2
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
EN
SE-DV54
25