510(k) K081445— FORA COMFORTSCAN EAR THERMOMETER, MODELS TD-1261A; TD-1261B

Substantially Equivalent

Taidoc Technology Corporation

Clearance details

Applicant: Taidoc Technology Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2008-05-22
Decision date: 2008-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.