PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)— 510(k) K060189
Substantially EquivalentIves Eeg Solutions, Inc.
FDA 510(k) clearance K060189 for PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE), Substantially Equivalent on 2006-05-30. 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
Recent devices under product code GXZ
view allMore clearances from Ives Eeg Solutions, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.