K233280
- 510(k) number
- K233280
- Device name
- SteadyTemp
- Applicant
- Steadysense GmbH AT
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2024-06-21
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233280.pdf
Official FDA record: K233280
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.