Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

K-Number: K181239 · 2018-10-29

ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2018-10-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2018-10-29 under approval number K181239. 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 Forehead Thermometer, Infrared Ear/Forehead Thermometer?

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-10-29. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K181239.

When was Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer approved by the FDA?

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer received FDA 510(k) clearance on 2018-10-29, under approval number K181239.

What company makes Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer?

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

What is the FDA product code for Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer?

The FDA product code for Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is FLL.

Related Clinical Trials

NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Other Devices by Joytech Healthcare Co. , Ltd.

K172989Electric Breast Pump K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors K163518Digital Thermometer K181081Infrared Ear Thermometer K173024Non-invasive blood pressure measurement systems K183393Digital Thermometer

View all 22 devices →

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.

↑