510(k) K231457 ยท GWQ Full-Montage Standard Electroencephalograph
SPARK Scan
| Applicant | Spark Neuro, Inc., New York NY, US |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | May 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231457
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.