Ce Conformity; Usa Regulations - Kodak Point-of-Care CR 120 Hardware Manual

CE Conformity

USA Regulations

This product conforms to the requirements of council directive 93/42/EEC.
The Kodak Point-of-Care CR 120/140 is a Class I medical device. The Kodak
Point-of-Care CR 120/140 bears the following mark of conformity:
European Authorized Representative
Carestream Health Deutschland GmbH
Product Safety
Hedelfinger Str. 60
70327 Stuttgart, Germany
Telephone: 49-711-406-2993
The FDA cleared the system for sale in the USA.
CAUTION
:
Federal US law restricts this device for sale by or on the order
of a physician.
6H8044
Safety and Regulatory Information
.
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