Eb Neuro S.P.A.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Eb Neuro S.P.A.” (first 2001, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 25 |
| 2013 | 0 | — |
| 2014 | 1 | 103 |
| 2015 | 2 | 200 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 57 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eb Neuro S.P.A. took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | 8 | 8 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
- Neurology (12)
- Anesthesiology (1)
Most recent Eb Neuro S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242832 | NExT Station; NExT Station Advanced | GWL | 2024-12-12 | 84 |
| K242305 | BE Plus PRO, Neurotravel LIGHT | GWL | 2024-09-04 | 30 |
| K150220 | STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast | GWF | 2015-08-19 | 201 |
| K142064 | GALILEO NT | OLT | 2015-02-13 | 198 |
| K133517 | NEMUS 2 SYSTEM | GWL | 2014-02-26 | 103 |
| K121996 | BE PLUS LTM AMPLIFIER GWI AMPLIFIER | GWL | 2012-08-03 | 25 |
| K093728 | BE MICRO, TREA | OLV | 2010-04-29 | 147 |
| K073415 | NEMUS SYSTEM; NEMUS PC PERIPHERAL | IKN | 2008-05-23 | 171 |
| K061996 | SANDMAN POCKET | MNR | 2006-10-03 | 81 |
| K053606 | BE PLUS / AURA-LTM64 AMPLIFIER | GWL | 2006-01-24 | 28 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eb Neuro S.P.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eb Neuro S.P.A.?
FDA lists 13 510(k) clearances under the applicant name “Eb Neuro S.P.A.” (first 2001, latest 2024), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eb Neuro S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eb Neuro S.P.A. is 84 days.
Which FDA product codes appear under Eb Neuro S.P.A.?
The most frequent FDA product codes under this applicant name are GWL (Amplifier, Physiological Signal, 8); GWF (Stimulator, Electrical, Evoked Response, 1); IKN (Electromyograph, Diagnostic, 1).
Next steps
- See all 13 Eb Neuro S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code GWL, Eb Neuro S.P.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.