510(k) K243225 ยท BZD Ventilator, Non-Continuous (Respirator)
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
| Applicant | Genadyne Biotechnologies, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Dec 31, 2024 |
| Received | Oct 8, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243225
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.