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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, Transducer Signal
510(k) Number K870783
Device Name BPA CARDIOVASCULAR PRESSURE AMPLIFIER
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 Number870.2060
Classification Product Code
DRQ  
Date Received02/26/1987
Decision Date 04/27/1987
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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