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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K854505
Device Name CARDIMAX FX-406U
Applicant
Brentwood Instruments, Inc.
2909 Oregon Ct.
Torrance,  CA  90503
Applicant Contact RICHARD ROSENTHAL
Correspondent
Brentwood Instruments, Inc.
2909 Oregon Ct.
Torrance,  CA  90503
Correspondent Contact RICHARD ROSENTHAL
Regulation Number870.2850
Classification Product Code
DRS  
Date Received11/12/1985
Decision Date 02/04/1986
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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