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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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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