K243000
- 510(k) number
- K243000
- Device name
- Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
- Applicant
- Shenzhen Medke Technology Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2025-06-20
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243000.pdf
Official FDA record: K243000
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.