Ce Conformity - Otto Bock 3C96-1 Instructions For Use Manual

4.8 CE Conformity

The electronic 3C96-1 / 3C86-1 C-Leg compact Prosthesis System meets the requirements of the 93 / 42 / EEC guide-
lines for medical devices. This product has been classified as a class I device according to the classification criteria
outlined in appendix IX of the guidelines. The declaration of conformity was therefore created by Ottobock with sole
responsibility according to appendix VII of the guidelines.
The electronic 3C96-1 / 3C86-1 C-Leg compact Prosthesis System also meets the requirements of the 1999 / 5 / EC
guidelines for radio equipment and telecommunications terminal equipment. Conformity assessment was carried out by
Ottobock according to appendix IV of the guidelines. A copy of the declaration of conformity can be requested from the
manufacturer (see back side).
C-Leg compact Prosthetic System
C-Leg Service
USA 800-328-4058
Canada 800-665-3327
Great Britain 1784 744 900
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