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510(k) K082077

BT3/6, BT12 by Corscience GmbH & Co. KG — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2008
Date Received
July 23, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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