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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 K251607
Device Name Oxygen Concentrator (J5A)
Applicant
Foshan Kycare Medical Equipment Co., Ltd.
Rm. 401, Bldg. 29, Liandong Yougu Park, # 3
Dongsan District, Jiansha Rd., Danzao Town, Nanhai District
Foshan,  CN 528000
Applicant Contact Leona Zhou
Correspondent
Pure Global
111 Town Sq. Pl.
Suite 1203
Jersey City,  NJ  07310
Correspondent Contact Jarvis Wu
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/27/2025
Decision Date 11/21/2025
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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