K250401
- 510(k) number
- K250401
- Device name
- AION TempShield
- Applicant
- Aion Biosystems, Inc. MA · US
- Product code
- FLL — Continuous Measurement Thermometer
- Decision date
- 2025-03-14
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K250401.pdf
Official FDA record: K250401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.