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FDA 510(k)

Infrared Ear Thermometer

K-Number: K180387 · 2019-01-10

ApplicantHetaida Technology Co., Ltd.
Decision Date2019-01-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Ear Thermometer is a medical device manufactured by Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under approval number K180387. 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 Ear Thermometer?

Infrared Ear Thermometer is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Hetaida Technology Co., Ltd.. The 510(k) number is K180387.

When was Infrared Ear Thermometer approved by the FDA?

Infrared Ear Thermometer received FDA 510(k) clearance on 2019-01-10, under approval number K180387.

What company makes Infrared Ear Thermometer?

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

What is the FDA product code for Infrared Ear Thermometer?

The FDA product code for Infrared Ear Thermometer is FLL.

Other Devices by Hetaida Technology Co., Ltd.

K171888Non-contact infrared body thermometer K180385Infrared Body 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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