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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 K251764
Device Name Oxygen Concentrator-P2-O5E
Applicant
Qingdao Kingon Medical Science and Technology Co., Ltd.
Rm. 301-302, #15 Hancheng Rd., Qingdao Free Trade Zone
24th Bldg., # 252 Yanhe Rd., Huangdao
Qingdao,  CN 266510
Applicant Contact Zhang Benrong
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/09/2025
Decision Date 12/22/2025
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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