FDA 510(k) Application Details - K983864

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

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510(K) Number K983864
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant MENNEN MEDICAL, INC.
KIRYAT WEIZMANN SCIENCE PARK
P.O. BOX 102
REHOVOT 76100 IL
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Contact KENNETH RAICHMAN
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 11/02/1998
Decision Date 10/08/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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