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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 K860249
Device Name THE HOLTER REPORTER (TM)
Applicant
Applied Cardiac Systems
22912 El Pacifico Dr.
Laguna Hills,  CA  92653
Applicant Contact DAN MARCUS
Correspondent
Applied Cardiac Systems
22912 El Pacifico Dr.
Laguna Hills,  CA  92653
Correspondent Contact DAN MARCUS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/24/1986
Decision Date 03/11/1986
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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