K250878
- 510(k) number
- K250878
- Device name
- YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2025-05-22
- Date received
- 2025-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K250878.pdf
Official FDA record: K250878
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.