Pulse Oximeter

Oximeter

Shanghai Berry Electronic Tech Co., Ltd

The following data is part of a premarket notification filed by Shanghai Berry Electronic Tech Co., Ltd with the FDA for Pulse Oximeter.

Pre-market Notification Details

Device IDK142687
510k NumberK142687
Device Name:Pulse Oximeter
ClassificationOximeter
Applicant Shanghai Berry Electronic Tech Co., Ltd Unit C, 1st Floor, 7th Building, No. 1188 Lianhang Road Shanghai,  CN
ContactXuezhi Yin
CorrespondentRay Wang
Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Beijing,  CN
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-22
Decision Date2015-04-13
Summary:summary

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