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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name encephalogram telemetry system
510(k) Number K891405
Device Name BMS-2000 MOBILE EEG SYSTEM
Applicant
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
BUCKMAN CO., INC.
921 CALLE VERDE
MARTINEZ,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number882.1855
Classification Product Code
GYE  
Date Received03/14/1989
Decision Date 08/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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