FDA 510(k) Application Details - K133540

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

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510(K) Number K133540
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY, UT 84107 US
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Contact PAUL DRYDEN
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 11/18/2013
Decision Date 03/28/2014
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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