510(k) K260578 · GXY Electrode, Cutaneous
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/
| Applicant | Ambu A/S, Ballerup, DK |
| Decision | Substantially Equivalent, Jul 14, 2026 |
| Received | Feb 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260578
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.