Neurovirtual USA, Inc.
Fort Lauderdale, FL, US
NEUROVIRTUAL USA, INC. appears in FDA device records in Fort Lauderdale, FL. FDA records list 8 510(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 8 510(k) clearances for Neurovirtual USA, Inc. between 2006 and 2020. The busiest year on record is 2020, with 3. The most recent is 2020, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2011 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201495 | Maxxi Flow Sensor | MNR | Substantially Equivalent | |
| K191492 | Maxxi Position Sensor | GWQ | Substantially Equivalent | |
| K191095 | Maxxi Snore Sensor | MNR | Substantially Equivalent | |
| K171304 | Maxxi Rip Sensor | MNR | Substantially Equivalent | |
| K163547 | MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 | GXY | Substantially Equivalent | |
| K131335 | BWMINI EEG, BWMINIHST, BWMINI PSG | GWQ | Substantially Equivalent | |
| K112107 | BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS | GWQ | Substantially Equivalent | |
| K062533 | BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 | OLT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006125362 | 3006125362 | NEUROVIRTUAL USA, INC. | 3303 W Commercial Blvd, Fort Lauderdale, FL 33309 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CATCannula, Nasal, Oxygen
- GXYElectrode, Cutaneous
- GWQFull-Montage Standard Electroencephalograph
- BZQMonitor, Breathing Frequency
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- OLVStandard Polysomnograph With Electroencephalograph
- MNRVentilatory Effort Recorder
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