510(k) K233829 ยท BZD Ventilator, Non-Continuous (Respirator)
Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (
| Applicant | Fisher and Paykel Healthcare Limited, Auckland, NZ |
| Decision | Substantially Equivalent, Aug 23, 2024 |
| Received | Dec 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233829
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.