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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K903917
Device Name COMPACT MONITOR SMK 210,211,230,231,240
Applicant
Ppg Hellige B.V.
D-7800 Freiburg
West Germany,  DE
Applicant Contact RUDOLF HERZ
Correspondent
Ppg Hellige B.V.
D-7800 Freiburg
West Germany,  DE
Correspondent Contact RUDOLF HERZ
Regulation Number870.3535
Classification Product Code
DSP  
Date Received08/24/1990
Decision Date 01/18/1991
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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