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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 K894956
Device Name CIRCAMED HOLTER VERSION 4
Applicant
Circadian, Inc.
3942 N. First St.
San Jose,  CA  95134
Applicant Contact ROBERT LEISER
Correspondent
Circadian, Inc.
3942 N. First St.
San Jose,  CA  95134
Correspondent Contact ROBERT LEISER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/04/1989
Decision Date 02/05/1990
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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