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FDA 510(k)

Digital Thermometer

K-Number: K163518 · 2017-09-19

ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2017-09-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital Thermometer is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2017-09-19 under approval number K163518. 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 Digital Thermometer?

Digital Thermometer is a medical device that received FDA 510(k) clearance on 2017-09-19. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K163518.

When was Digital Thermometer approved by the FDA?

Digital Thermometer received FDA 510(k) clearance on 2017-09-19, under approval number K163518.

What company makes Digital Thermometer?

Digital Thermometer is manufactured by Joytech Healthcare Co. , Ltd..

What is the FDA product code for Digital Thermometer?

The FDA product code for Digital Thermometer is FLL.

Other Devices by Joytech Healthcare Co. , Ltd.

K172989Electric Breast Pump K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors K181239Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer K181081Infrared Ear 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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