Cleared Traditional

Infrared Thermometer

K181215 · Shenzhen Finicare Co., Ltd. · General Hospital
Jan 2019
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K181215 is an FDA 510(k) clearance for the Infrared Thermometer, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Shenzhen Finicare Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 2, 2019, 240 days after receiving the submission on May 7, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number K181215 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2018
Decision Date January 02, 2019
Days to Decision 240 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.

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