Identity
- Trade Name
- eego amplifier FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- StimGuide component FDA UDI
- Model / Reference
- EE-410 FDA UDI
- Description
- StimGuide component FDA UDI
Identifiers
- Primary DI / UDI-DI
- B195EE410 FDA UDI
- 510(k) Number
- K183376 FDA UDI
- FDA Product Code
- IKN FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electroencephalographic signal amplifier
eego amplifier by eemagine Medical Imaging Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183376 also covers:
- HORIZON™ 230V US Mains Filter — The Magstim Company , Ltd.
- StimGuide BNC Ground Lead — The Magstim Company , Ltd.
- StimGuide RS232 Lead — The Magstim Company , Ltd.
- StimGuide Trigger Lead — The Magstim Company , Ltd.
- stimguide — eemagine Medical Imaging Solutions GmbH
- stimguide — eemagine Medical Imaging Solutions GmbH
- stimguide — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
- tracking tools — eemagine Medical Imaging Solutions GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- eemagine Medical Imaging Solutions GmbH
Sources (1)
- FDA UDI 76ed0578-307a-409a-b443-87d3d1819bfb 35 fields · synced May 30, 2026