Portable Oxygen Concentrator, Model: P2-E6

Generator, Oxygen, Portable

Qingdao Kingon Medical Science And Technology Co., Ltd.

The following data is part of a premarket notification filed by Qingdao Kingon Medical Science And Technology Co., Ltd. with the FDA for Portable Oxygen Concentrator, Model: P2-e6.

Pre-market Notification Details

Device IDK210371
510k NumberK210371
Device Name:Portable Oxygen Concentrator, Model: P2-E6
ClassificationGenerator, Oxygen, Portable
Applicant Qingdao Kingon Medical Science And Technology Co., Ltd. Room 301-302, No.15 HanchengRoad Qingdao Free Trade Zone,  CN 266555
ContactZhang Benrong
CorrespondentYou Yijie
Qimmiq Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou,  CN 510663
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2022-06-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971882890093 K210371 000

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