Declaration Of Conformity - DeVilbiss Healthcare SleepCube DV54 Serie Manual Del Usuario

DEclaration of conformity

DeClaRaTion of ConfoRmiTy
0044
Manufacturer:
Address:
Product Designation:
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:
Quality System
Standards Applied:
Notified Body:
Safety Standards Applied:
EMC Compliance To:
Authorized Representative: DeVilbiss Healthcare GmbH
DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
CPAP UMDNS 11-001
DeVilbiss IntelliPAP or SleepCube DV5x Series CPAP
– Models DV51 Standard 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
EN
SE-DV54-1
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