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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K950989
Device Name CARDIOSMART
Applicant
Hellige GmbH
Heinrich Von Stephan Strabe4
D7800 Freiburg Im Breisga,  DE
Applicant Contact KLAUS RUDOLF
Correspondent
Hellige GmbH
Heinrich Von Stephan Strabe4
D7800 Freiburg Im Breisga,  DE
Correspondent Contact KLAUS RUDOLF
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/03/1995
Decision Date 05/13/1996
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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