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FDA 510(k)

Infrared Body Thermometer

K-Number: K180385 · 2018-05-11

ApplicantHetaida Technology Co., Ltd.
Decision Date2018-05-11
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Body Thermometer is a medical device manufactured by Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-11 under approval number K180385. 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 Body Thermometer?

Infrared Body Thermometer is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Hetaida Technology Co., Ltd.. The 510(k) number is K180385.

When was Infrared Body Thermometer approved by the FDA?

Infrared Body Thermometer received FDA 510(k) clearance on 2018-05-11, under approval number K180385.

What company makes Infrared Body Thermometer?

Infrared Body Thermometer is manufactured by Hetaida Technology Co., Ltd..

What is the FDA product code for Infrared Body Thermometer?

The FDA product code for Infrared Body Thermometer is FLL.

Other Devices by Hetaida Technology Co., Ltd.

K171888Non-contact infrared body thermometer K180387Infrared Ear Thermometer K203332Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C K200159Non-contact Infrared Body Thermometer, model:HTD8823US K223170Electronic Blood Pressure Monitor, model: HTD6602US K241202Electric nasal aspirator (HTD2601US)

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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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