AVITA TSO/TS1 INFRARED EAR THERMOMETER— 510(k) K002182

Substantially Equivalent

Avita Corporation

FDA 510(k) clearance K002182 for AVITA TSO/TS1 INFRARED EAR THERMOMETER, Substantially Equivalent on 2000-12-29. Applicant: Avita Corporation.

Clearance details

Applicant: Avita Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2000-07-19
Decision date: 2000-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flaggstaff, AZ, 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.