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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 K871572
Device Name RHYTHMSCAN
Applicant
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Applicant Contact JAMES OBERMAYER
Correspondent
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Correspondent Contact JAMES OBERMAYER
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/22/1987
Decision Date 02/22/1988
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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