K251160
- 510(k) number
- K251160
- Device name
- Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2026-01-08
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251160.pdf
Official FDA record: K251160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.