510(k) K171384 ยท GWQ Full-Montage Standard Electroencephalograph
Micromed BRAIN QUICK system
| Applicant | Micromed S.P.A., Mogliano Veneto, IT |
| Decision | Substantially Equivalent, Feb 1, 2018 |
| Received | May 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171384
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | Micromed S.p.A. SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02 Open, Classified |
GWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.