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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 K223379
Device Name Portable Oxygen Concentrator (Model: P2-E7, P2-E)
Applicant
Qingdao Kingon Medical Science and Technology Co., Ltd.
Rm. 301-302, #15 Hanchengroad
Qingdao Free Trade Zone,  CN 266555
Applicant Contact Zhang Benrong
Correspondent
Qingdao Kingon Medical Science and Technology Co., Ltd.
Rm.1711, Bldg. K, #101 Science Ave. International
Creative Valley
Qingdao Free Trade Zone,  CN 266555
Correspondent Contact Zhang Benrong
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/07/2022
Decision Date 06/22/2023
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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