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FDA 510(k)

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

K-Number: K232128 · 2023-10-14

ApplicantShenzhen AOJ Medical Technology Co., Ltd.
Decision Date2023-10-14
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) is a medical device manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-14 under approval number K232128. 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 Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)?

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) is a medical device that received FDA 510(k) clearance on 2023-10-14. It is manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K232128.

When was Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) approved by the FDA?

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) received FDA 510(k) clearance on 2023-10-14, under approval number K232128.

What company makes Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)?

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) is manufactured by Shenzhen AOJ Medical Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)?

The FDA product code for Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) is FLL.

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.

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