AVITA INFRARED THEROMETER WITH BLUETOOTH— 510(k) K110559

Substantially Equivalent

Avita Corporation

FDA 510(k) clearance K110559 for AVITA INFRARED THEROMETER WITH BLUETOOTH, Substantially Equivalent on 2012-01-06. Applicant: Avita Corporation.

Clearance details

Applicant: Avita Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2011-02-28
Decision date: 2012-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, 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.