Declaration Of Conformity - Sunrise Medical DeVilbiss FlexSet 9354 Serie Guía De Instrucciones

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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: IS09001/ISO13485
Notified Body
MDD Annex II Applied
Authorized Representative:
0044
®Registered U.S. Patent and Trademark Office and other countries.
A-9354
Sunrise Medical
Respiratory Products Division
100 DeVilbiss Drive
Somerset, Pennsylvania 15501-2125 USA
Nasal CPAP Mask
DeVilbiss® FlexSet™ Mask, 9354 Series
IIa Rule 2
RWTÜV
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688
D e c l a r a t i o n o f C o n f o r m i t y