K250470
- 510(k) number
- K250470
- Device name
- Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2025-06-23
- Date received
- 2025-02-18
- 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: K250470.pdf
Official FDA record: K250470
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.