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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
Applicant
Foshan Mic Medical Technology Co., Ltd.
U501-1,503, 5f, #7 Bldg., Zone A Hantian
Industrial Park 17th Shenhai R
Foshan,  CN 528200
Applicant Contact Wu Huahong
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz.,
Shuixi Rd., Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number868.5440
Classification Product Code
CAW  
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
Predetermined Change
Control Plan Authorized		 No
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