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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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More FDA Info for this Product Code
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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