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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Pacemaker Electrode Function
510(k) Number K022360
Device Name 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.
Applicant
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact Jon Brumbaugh
Correspondent
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact Jon Brumbaugh
Regulation Number870.3720
Classification Product Code
DTA  
Date Received07/19/2002
Decision Date 01/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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