Pulse Oximeter


Dongguan Lingxin Technologies Co., LTD

The following data is part of a premarket notification filed by Dongguan Lingxin Technologies Co., Ltd with the FDA for Pulse Oximeter.

Pre-market Notification Details

Device IDK210305
510k NumberK210305
Device Name:Pulse Oximeter
Applicant Dongguan Lingxin Technologies Co., LTD Room 301, No. 3 Liantang Road, Aoshitang, Dongcheng Street Dongguan,  CN 523129
ContactCony Tang
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Mangement Consulting., Ltd Room 1813 Of Gebu Commercial Building, Hongxing, Songgang Street, Baoan District Shenzhen,  CN 518000
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-03
Decision Date2021-12-22

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