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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 K221734
Device Name Maxtec MaxO2 ME+p
Applicant
Maxtec, LLC
2305 South 1070 West
Salt Lake City,  UT  84119
Applicant Contact Sidra Hankins
Correspondent
ProMedic Consulting LLC
131 Bay Point Dr NE
Saint Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1720
Classification Product Code
CCL  
Subsequent Product Code
CAP  
Date Received06/15/2022
Decision Date 04/01/2023
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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