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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 K190304
Device Name Kingon P2 Oxygen Concentrator
Applicant
Qingdao Kingon Medical Science and Technology Co.
24th East Building, No. 252 Yanhe Road, Tianhe Industrial
Park, Huangdao
Qingdao,  CN
Applicant Contact Roman Huang
Correspondent
Elliot Medical Solutions
Parkland Drive
Cleveland Heights,  OH  44106
Correspondent Contact Roman Huang
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/12/2019
Decision Date 02/29/2020
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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