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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 K850702
Device Name CARDIOVIT CS-6 ECG-RECORDER
Original Applicant
SCHILLER AG
ch-6340 baar, altgasse 68
switzerland,  CH
Original Contact peter weber
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/21/1985
Decision Date 04/25/1985
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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