Declaration Of Conformity - Esaote P80 Guide De L'utilisateur

DECLARATION OF CONFORMITY

Electrocardiograph:
We, the undersigned, hereby declare that the medical device (class II a) specified above conforms with the
Essential Requirements listed in Annex I, of EC Directive 93/42/EEC
This declaration is supported by:
TÜV Product Service GmbH, Management Service, D – 80339 Munich
Certificate of approval No:
Q1Z 01 03 41505 002
G1 01 03 41505 001
Valid date 02/2004.
Baar (Switzerland), 21.03.2001
Markus Bütler
Quality Assurance Manager
DECLARATION OF CONFORMITY
Electrocardiograph:
We, the undersigned, hereby declare that the medical device (class II a) specified above conforms with the
Essential Requirements listed in Annex I, of EC Directive 93/42/EEC
This declaration is supported by:
TÜV Product Service GmbH, Management Service, D – 80339 Munich
Certificate of approval No:
Q1Z 01 03 41505 002
G1 01 03 41505 001
Valid date 02/2004.
Baar (Switzerland), 21.03.2001
Markus Bütler
Quality Assurance Manager
ESAOTE P-80 / P-80 White
DIN EN ISO 9001:2000 / DIN EN 46001:1996
Annex II, Section 3 of the Directive 93/42/EEC Medical Devices
ESAOTE P-80 / P-80 White
DIN EN ISO 9001:2000 / DIN EN 46001:1996
Annex II, Section 3 of the Directive 93/42/EEC Medical Devices
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