FDA 510(k)

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

K-Number: K213485 · 2022-05-25

ApplicantShenzhen AOJ Medical Technology Co., Ltd.

Decision Date2022-05-25

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E is a medical device manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under approval number K213485. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E?

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K213485.

When was Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E approved by the FDA?

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E received FDA 510(k) clearance on 2022-05-25, under approval number K213485.

What company makes Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E?

Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E is manufactured by Shenzhen AOJ Medical Technology Co., Ltd..

What is the FDA product code for Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E?

The FDA product code for Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E is FLL.

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Related PubMed Literature

PMID: 41192059 Computational modeling and simulation for medical devices: a summary of the 2024 FDA/MDIC Symposium. Progress in biomedical engineering (Bristol, England) (2026) PMID: 40424619 Digital Therapeutics in China: Comprehensive Review. Journal of medical Internet research (2025)

Other Devices by Shenzhen AOJ Medical Technology Co., Ltd.

K182190Fetal Doppler K182133Infrared Thermometer K191180Electronic Blood Pressure Monitor K202173Pulse Oximeter K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

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Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.