BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520— 510(k) K983295

Substantially Equivalent

Braun AG

FDA 510(k) clearance K983295 for BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520, Substantially Equivalent on 1999-03-15. Applicant: Braun AG.

Clearance details

Applicant: Braun AG
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1998-09-21
Decision date: 1999-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.