510(k) K191435 ยท GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
| Applicant | Nalu Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 6, 2019 |
| Received | May 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191435
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.