FDA 510(k) Application Details - K040484

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

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510(K) Number K040484
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant MAXTEC, INC.
6526 SOUTH COTTONWOOD ST.
SALT LAKE CITY, UT 84107 US
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Contact GORDON R ROTH
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Regulation Number 868.1720

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Classification Product Code CCL
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Date Received 02/25/2004
Decision Date 06/09/2004
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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