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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K211056
Device Name Oxus Sieve Beds
Applicant
Oxus, Inc.
2046 Brown Rd.
Auburn Hills,  MI  48326
Applicant Contact Ryan Lenarcic
Correspondent
Oxus, Inc. % Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/09/2021
Decision Date 05/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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