Pulse Oximeter

Oximeter

Shenzhen AOJ Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Pulse Oximeter.

Pre-market Notification Details

Device IDK202173
510k NumberK202173
Device Name:Pulse Oximeter
ClassificationOximeter
Applicant Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th Floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen,  CN 518126
ContactWendy Lin
CorrespondentWendy Lin
Shenzhen AOJ Medical Technology Co., Ltd. 601, 6th Floor, B2 Building, An'le Industrial Park #172 Hangcheng Avenue Shenzhen,  CN 518126
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2020-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06972040110473 K202173 000
06972040110466 K202173 000
06972040110459 K202173 000
06972040110442 K202173 000
06972040110435 K202173 000
06972040111067 K202173 000
06972040112569 K202173 000
06972040112552 K202173 000

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