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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 K874641
Device Name CIRCADIAN STRESS TEST II
Applicant
Circadian, Inc.
3942 N. First St.
San Jose,  CA  95134
Applicant Contact MATT S MAGOUN
Correspondent
Circadian, Inc.
3942 N. First St.
San Jose,  CA  95134
Correspondent Contact MATT S MAGOUN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/13/1987
Decision Date 04/01/1988
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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