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FDA 510(k)

Infrared Thermometer

K-Number: K182133 · 2018-11-20

ApplicantShenzhen AOJ Medical Technology Co., Ltd.
Decision Date2018-11-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer is a medical device manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-11-20 under approval number K182133. 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?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K182133.

When was Infrared Thermometer approved by the FDA?

Infrared Thermometer received FDA 510(k) clearance on 2018-11-20, under approval number K182133.

What company makes Infrared Thermometer?

Infrared Thermometer is manufactured by Shenzhen AOJ Medical Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

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

K182190Fetal Doppler 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 K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107

View all 17 devices →

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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