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FDA 510(k)

Infrared Thermometer

K-Number: K201980 · 2020-12-18

ApplicantContec Medical Systems Co.,Ltd
Decision Date2020-12-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer is a medical device manufactured by Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2020-12-18 under approval number K201980. 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 Thermometer?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Contec Medical Systems Co.,Ltd. The 510(k) number is K201980.

When was Infrared Thermometer approved by the FDA?

Infrared Thermometer received FDA 510(k) clearance on 2020-12-18, under approval number K201980.

What company makes Infrared Thermometer?

Infrared Thermometer is manufactured by Contec Medical Systems Co.,Ltd.

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

Other Devices by Contec Medical Systems Co.,Ltd

K152863Portable ECG Monitor K170856CMS600P2 B-Ultrasound Diagnostic System K170954Portable ECG Monitor K171360CONTEC™ Electrocardiograph K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

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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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