ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG— 510(k) K002631
Substantially EquivalentEemagine Medical Imaging Solutions GmbH
FDA 510(k) clearance K002631 for ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG, Substantially Equivalent on 2000-10-23. Applicant: Eemagine Medical Imaging Solutions GmbH. Device class: 2.
Clearance details
- Applicant
- Eemagine Medical Imaging Solutions GmbH
- Product code
- Code OLX
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mukwonago, WI, US
Recent devices under product code OLX
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