COGNITRACE— 510(k) K051825
Substantially EquivalentEemagine Medical Imaging Solutions GmbH
FDA 510(k) clearance K051825 for COGNITRACE, Substantially Equivalent on 2005-09-12. Applicant: Eemagine Medical Imaging Solutions GmbH. Device class: 2.
Clearance details
- Applicant
- Eemagine Medical Imaging Solutions GmbH
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deer Field, IL, US
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