510(k) K254213 ยท OLT Non-Normalizing Quantitative Electroencephalograph Software
Pascall Sensor Unit (PSU1)
| Applicant | Pascall Systems, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Aug 19, 2026 |
| Received | Dec 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254213
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.