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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 K251534
Device Name Oxygen Concentrator (J10A)
Applicant
Foshan Kycare Medical Equipment Co., Ltd.
Rm. 401, Bldg. 29, Liandong Yougu Park, No 3, Dongsan
District, Jiansha Rd., Danzao Town, Nanhai District
Foshan,  CN 528216
Applicant Contact Leona Zhou
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.
Huangpu District
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/19/2025
Decision Date 12/29/2025
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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