510(k) K253148 ยท MNR Ventilatory Effort Recorder
RX-1 Sleep
| Applicant | Vivaquant, Inc. Dba Rhythm Express, Arden Hills MN, US |
| Decision | Substantially Equivalent, Jun 22, 2026 |
| Received | Sep 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253148
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.