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FDA 510(k) Application Details - K951226
Device Classification Name
Computer, Blood-Pressure
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510(K) Number
K951226
Device Name
Computer, Blood-Pressure
Applicant
PACE TECH, INC.
510 GARDEN AVE. NORTH
CLEARWATER, FL 33755 US
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Contact
ILHAN M BILGUTAY
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Regulation Number
870.1110
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Classification Product Code
DSK
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More FDA Info for this Product Code
Date Received
03/20/1995
Decision Date
11/21/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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