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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Biopotential
510(k) Number K874441
Device Name BARD BIOPOTENTIAL AMPLIFIER
Applicant
C.R. Bard, Inc.
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Applicant Contact ERNEST MANFREDO
Correspondent
C.R. Bard, Inc.
5 Federal St.
P.O. Box 5069
Billerica,  MA  01822
Correspondent Contact ERNEST MANFREDO
Regulation Number870.2050
Classification Product Code
DRR  
Date Received10/28/1987
Decision Date 01/19/1988
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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