FDA 510(k) Application Details - K851486

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K851486
Device Name Transducer, Blood-Pressure, Extravascular
Applicant GOULD, INC.
1900 WILLIAMS DR.
OXNARD, CA US
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Contact ARCHER S GORDON
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 04/15/1985
Decision Date 10/17/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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