Cleared Traditional

BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER

K992468 · Braun GmbH · General Hospital

Oct 1999

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K992468 is an FDA 510(k) clearance for the BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Braun GmbH (San Diego, US). The FDA issued a Cleared decision on October 20, 1999, 89 days after receiving the submission on July 23, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K992468 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1999
Decision Date	October 20, 1999
Days to Decision	89 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.