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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 S. 1070 W.
Salt Lake City,  UT  84111
Applicant Contact JERALD WILSON
Correspondent
Maxtec, LLC
2305 S. 1070 W.
Salt Lake City,  UT  84111
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
Predetermined Change
Control Plan Authorized		 No
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