PEOPLE'S REPUBLIC OF CHINA
1.5.1 Declares that the CE-marketed product
Product Name:
Automatic External Defibrillator
Device Type:
BF
Model Number:
AED7000
Accessories:
See list in manual
Complies with Council Directive 93/42/EEC (Medical Device Directive) of
June 14 1993 class IIb Annex II
1.5.2 Standards
General: ISO13485:2003
ISO14155:2003
ISO14971:2007
EN980:2008
EN1041:1998
Safety: IEC60601-1:1988+A1:1991+A2:1995+A13:1996
Type BF, Internally Powered, Continuous
operation, Defibrillator Proof Operation
IEC60601-1-4:2000
IEC60601-1-6:2006
IEC60601-2-4:2002
IEC62304:2006
EMC: IEC60601-1-2:2007
1.6 Labels
Trademark
Manufacturer
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