K251160

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

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.