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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K851517
Device Name CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
Applicant
Circadian, Inc.
3942 N. First St.
San Jose,  CA  95134
Applicant Contact ROBERT J SUDOL
Correspondent
Circadian, Inc.
3942 N. First St.
San Jose,  CA  95134
Correspondent Contact ROBERT J SUDOL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/15/1985
Decision Date 10/02/1985
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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