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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, oxygen, gaseous-phase
510(k) Number K112402
Device Name ULTRAMAXO2 OXYGEN ANALYER
Applicant
MAXTEC, LLC
6526 Cottonwood St # 300
Salt Lake City,  UT  84107
Applicant Contact TAMMY LAVERY
Correspondent
MAXTEC, LLC
6526 Cottonwood St # 300
Salt Lake City,  UT  84107
Correspondent Contact TAMMY LAVERY
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/22/2011
Decision Date 12/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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