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510(k) K100383

VITAPHONE. MODEL 100 BT by Vitasystems GmbH — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2010
Date Received
February 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

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