510(k) K250401 · FLL Continuous Measurement Thermometer
AION TempShield
| Applicant | Aion Biosystems, Inc., Lowell MA, US |
| Decision | Substantially Equivalent, Mar 14, 2025 |
| Received | Feb 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250401
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.