510(k) K090395— FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E

Substantially Equivalent

Taidoc Technology Corporation

Clearance details

Applicant: Taidoc Technology Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2009-02-17
Decision date: 2009-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei County, 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.