NeuroOne Cortical Electrode— 510(k) K192764
Substantially EquivalentNeuroone, Inc.
FDA 510(k) clearance K192764 for NeuroOne Cortical Electrode, Substantially Equivalent on 2019-11-26. Applicant: Neuroone, Inc.. Device class: 2.
Clearance details
- Applicant
- Neuroone, Inc.
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.