Cleared Traditional

Infrared Thermometer

K201980 · Contec Medical Systems Co.,Ltd · General Hospital

Dec 2020

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K201980 is an FDA 510(k) clearance for the Infrared Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on December 18, 2020, 155 days after receiving the submission on July 16, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K201980 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2020
Decision Date	December 18, 2020
Days to Decision	155 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.