Neurowave Systems Inc.
Beachwood, OH, US
NEUROWAVE SYSTEMS INC. appears in FDA device records in Beachwood, OH. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Neurowave Systems Inc. between 2010 and 2021. The busiest year on record is 2010, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2015 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | OLW | Substantially Equivalent | |
| K142834 | DiscoverEEG System, Model DE-401 | OLT | Substantially Equivalent | |
| K092477 | NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 | OMC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008657519 | 3008657519 | NEUROWAVE SYSTEMS INC. | 25825 Science Park Dr, STE 250, Beachwood, OH 44122 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain