SUBDERMAL WIRE ELECTRODE, MODEL SWE— 510(k) K062880
Substantially EquivalentIves Eeg Solutions, Inc.
FDA 510(k) clearance K062880 for SUBDERMAL WIRE ELECTRODE, MODEL SWE, Substantially Equivalent on 2006-12-22. Applicant: Ives Eeg Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Ives Eeg Solutions, Inc.
- Product code
- Code GXZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1350
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manotick, Ontario, CA
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