K240109
- 510(k) number
- K240109
- Device name
- Medical electronic thermometer (FC01, FC02)
- Applicant
- Zhuzhou Goldenhot Medical Technology Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2024-04-12
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240109.pdf
Official FDA record: K240109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.