Cleared Special

BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER

K060006 · Braun GmbH · General Hospital

Jan 2006

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K060006 is an FDA 510(k) clearance for the BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Braun GmbH (Eagle, US). The FDA issued a Cleared decision on January 31, 2006, 28 days after receiving the submission on January 3, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K060006 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2006
Decision Date	January 31, 2006
Days to Decision	28 days
Submission Type	Special
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.