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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 K850454
Device Name CARDIO-3 CHANNEL ELECTROCARDIOGRAPH
Applicant
Zimmer Elektromedizin GmbH
Junkersstrabe 9
Postfach 22 80
7910 Neu-Ulm, Germany,  DE
Applicant Contact DETLEF GANSERA
Correspondent
Zimmer Elektromedizin GmbH
Junkersstrabe 9
Postfach 22 80
7910 Neu-Ulm, Germany,  DE
Correspondent Contact DETLEF GANSERA
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/06/1985
Decision Date 03/01/1985
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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