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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 K153659
Device Name MaxO2ME
Applicant
MAXTEC, LLC
2305 South 1070 West
Salt Lake City,  UT  84111 9
Applicant Contact JERALD WILSON
Correspondent
MAXTEC, LLC
2305 South 1070 West
Salt Lake City,  UT  84111 9
Correspondent Contact PAUL DRYDEN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/21/2015
Decision Date 06/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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