K240648
- 510(k) number
- K240648
- Device name
- Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
- Applicant
- Radiant Innovation, Inc. TW
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2024-06-05
- Date received
- 2024-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240648.pdf
Official FDA record: K240648
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.