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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K220591
Device Name Proxima
Applicant
Dynasthetics, LLC
3487 W. 2100 S. #300
Salt Lake City,  UT  84119
Applicant Contact Joseph Orr
Correspondent
Promedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
NFB  
Date Received03/01/2022
Decision Date 12/15/2022
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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