K010462

Substantially Equivalent

AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)

Applicant: Avita Corporation
Product code: FLL
Advisory panel: General Hospital
Date received: 2001-02-16
Decision date: 2001-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flaggstaff, AZ, US

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.