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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 K202389
Device Name Oxygen Concentrator
Foshan MIC Medical Technology Co., LTD
U501-1,503, 5F, No.7 Building, Zone A Hantian
Industrial Park 17th Shenhai R
Foshan,  CN 528200
Applicant Contact Wu Huahong
Share Info (Guangzhou) Medical Consultant Ltd.
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road,
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number868.5440
Classification Product Code
Date Received08/21/2020
Decision Date 04/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No