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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 K864320
Device Name SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact DAVID KORNHAUSER
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact DAVID KORNHAUSER
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received11/03/1986
Decision Date 02/20/1987
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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