Cleared Traditional

Infrared Forehead Thermometer

K202420 · Conmo Electronic Company Limited · General Hospital

Feb 2021

Decision

185d

Days

Class 2

Risk

About This 510(k) Submission

K202420 is an FDA 510(k) clearance for the Infrared Forehead Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Conmo Electronic Company Limited (Laibin City, CN). The FDA issued a Cleared decision on February 25, 2021, 185 days after receiving the submission on August 24, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K202420 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2020
Decision Date	February 25, 2021
Days to Decision	185 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.