K232128
- 510(k) number
- K232128
- Device name
- Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2023-10-14
- Date received
- 2023-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232128.pdf
Official FDA record: K232128
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.