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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 K862947
Device Name THE EXPERT MODELS RTS 2000 AND RTS 2000H
Applicant
Ocg Technology, Inc.
42 Executive Blvd.
Farmingdale,  NY  11735
Applicant Contact PETER T COBRIN
Correspondent
Ocg Technology, Inc.
42 Executive Blvd.
Farmingdale,  NY  11735
Correspondent Contact PETER T COBRIN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/05/1986
Decision Date 11/04/1987
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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