FDA 510(k) Application Details - K950197

Device Classification Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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510(K) Number K950197
Device Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant MICRO DIRECT, INC.
P.O. BOX 239
840 POWNAL ROAD
AUBURN, ME 04210-0239 US
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Contact DAVID R STASZAK
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Regulation Number 868.1430

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Classification Product Code CCJ
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Date Received 01/18/1995
Decision Date 10/17/1996
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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