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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 K252407
Device Name OxyGo Portable Oxygen Concentrator (1400-7000)
Applicant
Mv Life, LLC
2200 Principal Row
Orlando,  FL  32837
Applicant Contact Chris Carter
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Chhavy Tep-Cullison
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/31/2025
Decision Date 04/23/2026
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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