510(k) K250094 ยท GYC Electrode, Cortical
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (N
| Applicant | Neuralynx, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Apr 14, 2025 |
| Received | Jan 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250094
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.