FDA 510(k) Application Details - K843555

Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function

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510(K) Number K843555
Device Name Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant GOULD, INC.
1900 WILLIAMS DR.
OXNARD, CA US
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Contact ARCHER S GORDON
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Regulation Number 870.1435

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Classification Product Code DXG
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Date Received 09/10/1984
Decision Date 02/01/1985
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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