Neurovision Nerve Locator Monitor (Nerveana), EMGView Software— 510(k) K170677
Substantially EquivalentNeurovision Medical Product, Inc.
FDA 510(k) clearance K170677 for Neurovision Nerve Locator Monitor (Nerveana), EMGView Software, Substantially Equivalent on 2017-04-05. Applicant: Neurovision Medical Product, Inc..
Clearance details
- Applicant
- Neurovision Medical Product, Inc.
- Product code
- Code GWF
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ventura, CA, US
Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.