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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 K864465
Device Name CARDIOVIT AT-6
Applicant
SCHILLER CORP.
1601 ALTON AVE.
IRVINE,  CA  92714
Applicant Contact DAVID R JOHNSON
Correspondent
SCHILLER CORP.
1601 ALTON AVE.
IRVINE,  CA  92714
Correspondent Contact DAVID R JOHNSON
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/12/1986
Decision Date 03/20/1987
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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