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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 K853652
Device Name BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
Applicant
Fisher Imaging Corp.
125 S. Fifth St.
P.O. Box 0342
Reading,  PA  19603
Applicant Contact MURRAY BLOOM
Correspondent
Fisher Imaging Corp.
125 S. Fifth St.
P.O. Box 0342
Reading,  PA  19603
Correspondent Contact MURRAY BLOOM
Regulation Number870.2050
Classification Product Code
DRR  
Date Received09/03/1985
Decision Date 01/16/1986
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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