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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K882366
Device Name RHYTHMSCAN HR HOLTER RECORDER
Applicant
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Applicant Contact JIM SEAFORT
Correspondent
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Correspondent Contact JIM SEAFORT
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/08/1988
Decision Date 08/02/1988
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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