Braun Thermoscan PRO3000 Infared Thermometer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992468 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K031928 Active Cleared 24 Oct 2003

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  FDA 510(k) K003732 Active Cleared 16 May 2001

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  FDA 510(k) K061351 Active Cleared 5 Jun 2006

• Braun Thermoscan Irt 2000 Infrared Ear Thermometer

  Class II

  FDA 510(k) K060006 Active Cleared 31 Jan 2006

• Oral B Professionalcare Series, Oral B Advancepower Series

  Class I

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• What is the Braun ThermoScan Pro3000 used for?

  The Braun ThermoScan Pro3000 is an infrared thermometer designed for measuring body temperature. It utilizes infrared technology to provide accurate temperature readings, specifically intended for use in hospital settings.

• Is the Braun ThermoScan Pro3000 a single-use device?

  Yes, the Braun ThermoScan Pro3000 is supplied as a single-use device with disposable probe covers. This design helps maintain hygiene and ensures accurate readings with each use.

• What regulatory approvals does the Braun ThermoScan Pro3000 have?

  The Braun ThermoScan Pro3000 has received FDA 510(k) clearance with the product code FLL. It was determined to be substantially equivalent through the traditional clearance process and reviewed by the General Hospital advisory committee.

• How is the Braun ThermoScan Pro3000 supplied?

  The device is supplied with disposable probe covers, which are essential for maintaining hygiene and ensuring accurate temperature measurements. These probe covers are designed for single-use and should be replaced between patients.