FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER— 510(k) K020433

Substantially Equivalent

Idt Technology Limited

FDA 510(k) clearance K020433 for FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER, Substantially Equivalent on 2002-07-11. Applicant: Idt Technology Limited.

Clearance details

Applicant: Idt Technology Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2002-02-08
Decision date: 2002-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

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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.