510(k) K231313 ยท BZD Ventilator, Non-Continuous (Respirator)
Therapy Mask 3100 NC/SP
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jul 28, 2023 |
| Received | May 5, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231313
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.