FDA 510(k) Application Details - K953795

Device Classification Name Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

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510(K) Number K953795
Device Name Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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 868.1620

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Classification Product Code CBS
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Date Received 08/14/1995
Decision Date 07/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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