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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function, Indirect
510(k) Number K922742
Device Name HPM 40 HEART PACEMAKER MONITOR
Applicant
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035 -5369
Applicant Contact STEPHEN K DEOL
Correspondent
Biotronik, GmbH & Co.
6024 Southwest Jean Rd.
Unit B4
Lake Oswego,  OR  97035 -5369
Correspondent Contact STEPHEN K DEOL
Regulation Number870.3640
Classification Product Code
KRE  
Date Received06/08/1992
Decision Date 03/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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