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510(k) K073230

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS by Biotronik, Inc. — Product Code DTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
November 15, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pacemaker Electrode Function
Device Class
Class II
Regulation Number
870.3720
Review Panel
CV
Submission Type

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