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FDA 510(k)

Infrared Ear Thermometer

K-Number: K181081 · 2018-10-02

ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2018-10-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Ear Thermometer is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2018-10-02 under approval number K181081. 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 2018-10-02. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K181081.

When was Infrared Ear Thermometer approved by the FDA?

Infrared Ear Thermometer received FDA 510(k) clearance on 2018-10-02, under approval number K181081.

What company makes Infrared Ear Thermometer?

Infrared Ear Thermometer is manufactured by Joytech Healthcare 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 Joytech Healthcare Co. , Ltd.

K172989Electric Breast Pump K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors K163518Digital Thermometer K181239Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer K173024Non-invasive blood pressure measurement systems K183393Digital Thermometer

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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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