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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 K855145
Device Name MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
Applicant
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact GORDON PH.D.
Correspondent
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact GORDON PH.D.
Regulation Number870.2850
Classification Product Code
DRS  
Date Received12/24/1985
Decision Date 02/26/1986
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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