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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 K210371
Device Name Portable Oxygen Concentrator, model: P2-E6
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
Qimmiq Medical Consulting Service Co., Ltd.
Rm.1711, Bldg. K, #101 Science Ave.
International Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/08/2021
Decision Date 06/03/2022
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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