FDA 510(k) Application Details - K093525

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

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510(K) Number K093525
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant VENTLAB CORP.
155 BOYCE DRIVE
MOCKSVILLE, NC 27028 US
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Contact JAMES A COCHIE
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 11/16/2009
Decision Date 12/10/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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