TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370— 510(k) K090564

Substantially Equivalent

Truly Instrument Limited

FDA 510(k) clearance K090564 for TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370, Substantially Equivalent on 2009-06-24. Applicant: Truly Instrument Limited.

Clearance details

Applicant: Truly Instrument Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2009-03-02
Decision date: 2009-06-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shanwei City, Guangdong, CN

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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.