MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96— 510(k) K163547
Substantially EquivalentNeurovirtual USA, Inc.
FDA 510(k) clearance K163547 for MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96, Substantially Equivalent on 2017-04-11. Applicant: Neurovirtual USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Neurovirtual USA, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Doral, FL, US
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