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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K220290
Device Name Revitalair 430+
Applicant
Us Hyperbaric Network
7600 NW 69th Ave.
Medley,  FL  33166
Applicant Contact Jorge Millan
Correspondent
Us Hyperbaric Network
7600 NW 69th Ave.
Medley,  FL  33166
Correspondent Contact Jorge Millan
Regulation Number868.5470
Classification Product Code
CBF  
Date Received02/01/2022
Decision Date 05/04/2023
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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