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510(k) K022360

ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. by Biotronik, Inc. — Product Code DTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2003
Date Received
July 19, 2002
Clearance Type
Traditional
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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