510(k) K243136— Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)

Substantially Equivalent

Shenzhen Finicare Co., Ltd.

Clearance details

Applicant: Shenzhen Finicare Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2024-09-30
Decision date: 2025-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.