Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D And AOJ-25E

Thermometer, Electronic, Clinical

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 Digital Thermometer, Models: Aoj-25a, Aoj-25b, Aoj-25c, Aoj-25d And Aoj-25e.

Pre-market Notification Details

Device IDK213485
510k NumberK213485
Device Name:Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D And AOJ-25E
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan District Shenzhen,  CN 518126
ContactQueena Chen
CorrespondentQueena Chen
Shenzhen AOJ Medical Technology Co., Ltd. Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan District Shenzhen,  CN 518126
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-29
Decision Date2022-05-25

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.