Kingon P2 Oxygen Concentrator

Generator, Oxygen, Portable

Qingdao Kingon Medical Science And Technology Co.

The following data is part of a premarket notification filed by Qingdao Kingon Medical Science And Technology Co. with the FDA for Kingon P2 Oxygen Concentrator.

Pre-market Notification Details

Device IDK190304
510k NumberK190304
Device Name:Kingon P2 Oxygen Concentrator
ClassificationGenerator, Oxygen, Portable
Applicant Qingdao Kingon Medical Science And Technology Co. 24th East Building, No. 252 Yanhe Road, Tianhe Industrial Park, Huangdao Qingdao,  CN
ContactRoman Huang
CorrespondentRoman Huang
Elliot Medical Solutions Parkland Drive Cleveland Heights,  OH  44106
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-12
Decision Date2020-02-29

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