K243136
- 510(k) number
- K243136
- Device name
- Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
- Applicant
- Shenzhen Finicare Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2025-02-14
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243136.pdf
Official FDA record: K243136
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.