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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 K851486
Device Name GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
Applicant
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ARCHER S GORDON
Correspondent
Gould, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ARCHER S GORDON
Regulation Number870.2850
Classification Product Code
DRS  
Date Received04/15/1985
Decision Date 10/17/1985
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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