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FDA 510(k)

iHealth Infrared No-Touch Forehead Thermometer

K-Number: K200531 · 2020-07-15

ApplicantAndon Health Co, Ltd.
Decision Date2020-07-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iHealth Infrared No-Touch Forehead Thermometer is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2020-07-15 under approval number K200531. 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 iHealth Infrared No-Touch Forehead Thermometer?

iHealth Infrared No-Touch Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K200531.

When was iHealth Infrared No-Touch Forehead Thermometer approved by the FDA?

iHealth Infrared No-Touch Forehead Thermometer received FDA 510(k) clearance on 2020-07-15, under approval number K200531.

What company makes iHealth Infrared No-Touch Forehead Thermometer?

iHealth Infrared No-Touch Forehead Thermometer is manufactured by Andon Health Co, Ltd..

What is the FDA product code for iHealth Infrared No-Touch Forehead Thermometer?

The FDA product code for iHealth Infrared No-Touch Forehead Thermometer is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Other Devices by Andon Health Co, Ltd.

K153286iHealth Align Gluco-Monitoring system K153278Wireless Smart Gluco-Monitoring System K160565Fully Automatic Electronic Blood Pressure Monitor K160563Fully Automatic Electronic Blood Pressure Monitor K160014iHealth Track Blood Pressure Monitor K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)

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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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