Identity
- Trade Name
- g.Nautilus PRO FDA UDI
- Generic Name
- Multiple physiological signal amplifier FDA UDI
- Device Name
- The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. FDA UDI
- Model / Reference
- 16-Channel Sahara FDA UDI
- Description
- The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. FDA UDI
Identifiers
- Catalog Number
- 5210PRO FDA UDI
- Primary DI / UDI-DI
- EBCI5210PRO0 FDA UDI
- 510(k) Number
- K171669 FDA UDI
- FDA Product Code
- GXY FDA UDIGWL FDA UDI
- GMDN Term
- Multiple physiological signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI882.1835 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
Category: Multiple physiological signal amplifier
g.Nautilus PRO by g.tec medical engineering GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171669 also covers:
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering GmbH
- g.Nautilus PRO — g.tec medical engineering 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
- g.tec medical engineering GmbH
Sources (1)
- FDA UDI f29b17d9-a902-45a1-8359-7d0ede3d7342 38 fields · synced Jun 1, 2026