Cleared Abbreviated

BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)

K031928 · Braun GmbH · General Hospital

Oct 2003

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K031928 is an FDA 510(k) clearance for the BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT), a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Braun GmbH (Carlsbad, US). The FDA issued a Cleared decision on October 24, 2003, 123 days after receiving the submission on June 23, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K031928 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2003
Decision Date	October 24, 2003
Days to Decision	123 days
Submission Type	Abbreviated
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.