Declaration Of Conformity - DeVilbiss SleepCube DV53 Standard Plus CPAP User Manual

EN

DEclaration of conformity

DeClaRaTion of ConfoRmiTy
0044
Manufacturer:
Address:
ProductDesignation:
Type,Model:
We herewith declare that the above mentioned product complies with the requirements of
EC Directive 93/42/EEC + A2007 Annex II, 3
Class:
QualitySystem
StandardsApplied:
NotifiedBody:
SafetyStandardsApplied:
EMCComplianceTo:
AuthorizedRepresentative: DeVilbiss Healthcare GmbH
SE-DV53-1
36
DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP UMDNS 11-001
DeVilbiss IntelliPAP or SleepCube DV5x Series CPAP
– Models DV53 Standard Plus CPAP & DV54 AutoAdjust
DeVilbiss Heated Humidifier
– Model DV5HH
IIa, Rule 9
ISO13485:2003
TÜV NORD Cert GmbH
IEC 60601-1:1988 + A1 1995
IEC 60601-1-4:2000
ISO 14971:2007
EN ISO17510-1:2007
IEC 60601-1- 6:2004
IEC 60601-1-2:2001 + A1 2004
Kamenzer Straße 3
68309 Mannheim
Germany
+49 621-178-98-0