K232678
- 510(k) number
- K232678
- Device name
- Digital Thermometer, Model T28, T28L
- Applicant
- Guangdong Genial Technology Co., Ltd. CN
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2024-01-31
- Date received
- 2023-09-01
- 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: K232678
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.