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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K780404
Device Name ECG MONITORING SYSTEM,
Applicant
Quinton, Inc.
WA 
Correspondent
Quinton, Inc.
WA 
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/13/1978
Decision Date 03/28/1978
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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