K231625
- 510(k) number
- K231625
- Device name
- VitalDetect
- Applicant
- Wellvii, Inc. FL · US
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2024-02-02
- Date received
- 2023-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231625.pdf
Official FDA record: K231625
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.