BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER— 510(k) K060006

Substantially Equivalent

Braun GmbH

FDA 510(k) clearance K060006 for BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER, Substantially Equivalent on 2006-01-31. Applicant: Braun GmbH.

Clearance details

Applicant: Braun GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2006-01-03
Decision date: 2006-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Eagle, ID, US

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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.