FDA 510(k) Application Details - K955417

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

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510(K) Number K955417
Device Name Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant VITAL SIGNS, INC.
20 CAMPUS RD.
TOTOWA, NJ 07512 US
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Contact WHITNEY G TORNING
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Regulation Number 870.1435

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Classification Product Code DXG
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Date Received 11/27/1995
Decision Date 03/08/1996
Decision SESK - SUBST EQUIV - KIT
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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