FDA 510(k) Application Details - K131410

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

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510(K) Number K131410
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant SOUTHMEDIC, INC.
50 ALLIANCE BLVD.,
BARRIE, ONTARIO L4M 5K3 CA
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Contact TISH ANGER
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 05/15/2013
Decision Date 01/13/2014
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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