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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 K912427
Device Name MULTICHANNEL RECORDING SYSTEM
Applicant
Bionique
14225 Southwest Wilson Dr.
Beaverton,  OR  97005
Applicant Contact BRADY
Correspondent
Bionique
14225 Southwest Wilson Dr.
Beaverton,  OR  97005
Correspondent Contact BRADY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/31/1991
Decision Date 07/26/1991
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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