Infrared Thermometer TET-351— 510(k) K220276

Substantially Equivalent

Truly Instrument Limited

FDA 510(k) clearance K220276 for Infrared Thermometer TET-351, Substantially Equivalent on 2023-02-17. Applicant: Truly Instrument Limited.

Clearance details

Applicant: Truly Instrument Limited
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2022-01-31
Decision date: 2023-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanwei, CN

Download summary PDF View on FDA.gov ↗

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.