K083299

Substantially Equivalent

TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THERMOMETERS & FORA IR16/17 EAR THERMOMETER

Applicant: Taidoc Technology Corporation
Product code: FLL
Advisory panel: General Hospital
Date received: 2008-11-10
Decision date: 2008-12-10
Decision: Substantially Equivalent
Clearance type: Special
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.