VIVOSONIC NEUROSCREEN— 510(k) K080060
Substantially EquivalentVivosonic, Inc.
FDA 510(k) clearance K080060 for VIVOSONIC NEUROSCREEN, Substantially Equivalent on 2008-04-04. Applicant: Vivosonic, Inc.. Device class: 2.
Clearance details
- Applicant
- Vivosonic, Inc.
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, On, CA
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