BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)— 510(k) K031928

Substantially Equivalent

Braun GmbH

FDA 510(k) clearance K031928 for BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT), Substantially Equivalent on 2003-10-24. Applicant: Braun GmbH.

Clearance details

Applicant: Braun GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-06-23
Decision date: 2003-10-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.