FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
K Number: K240575
·
Decision Nov 25, 2024
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
8
Review Days
269
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Basic Information
- Device Name
- WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
- K Number
- K240575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eemagine Medical Imaging Solutions GmbH
- Date Received
- March 1, 2024
- Decision Date
- November 25, 2024
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Eemagine Medical Imaging Solutions GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K210109 | visor2 system | Apr 8, 2022 | Substantially Equivalent |
| K192889 | Neo | Jan 30, 2020 | Substantially Equivalent |
| K172312 | eego amplifiers | Mar 30, 2018 | Substantially Equivalent |
| K110223 | WAVEGUARD (TM) EEG CAP | Jun 29, 2011 | Substantially Equivalent |
| K070358 | MAXINSIGHT | Jul 30, 2007 | Substantially Equivalent |
| K051825 | COGNITRACE | Sep 12, 2005 | Substantially Equivalent |
| K002631 | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | Oct 23, 2000 | Substantially Equivalent |