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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 K870554
Device Name CASSETTE TAPE REPLAY SYSTEM
Applicant
Research Instrumentation Associates, Inc.
23850 Commerce Park
Beachwood,  OH  44122
Applicant Contact STROTHER, JR
Correspondent
Research Instrumentation Associates, Inc.
23850 Commerce Park
Beachwood,  OH  44122
Correspondent Contact STROTHER, JR
Regulation Number870.2800
Classification Product Code
DSH  
Date Received02/10/1987
Decision Date 03/23/1987
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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