DeVilbiss SleepCube DV53 Standard Plus CPAP - Declaration of Conformity; Manufacturer and Product Details; Compliance Standards and Notified Body; Authorized Representative Information

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