K232338
- 510(k) number
- K232338
- Device name
- Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
- Applicant
- Alicn Medical Shenzhen, Inc. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2023-12-22
- Date received
- 2023-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232338
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.