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g.Nautilus PRO

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K171669

by g.tec medical engineering GmbH

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-mB 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
5211PRO FDA UDI
Primary DI / UDI-DI
EBCI5211PRO0 FDA UDI
510(k) Number
K171669 FDA 510(k)FDA UDI
FDA Product Code
GWL FDA 510(k)FDA UDI
GXY FDA UDI
GMDN Term
Multiple physiological signal amplifier FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.1835 FDA 510(k)
Regulation Number
882.1835 FDA 510(k)FDA UDI
882.1320 FDA UDI
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

g.Nautilus PRO by g.tec medical engineering GmbH — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
g.tec medical engineering GmbH

Sources (2)

  • FDA 510(k) K171669 24 fields · synced Jun 19, 2026
  • FDA UDI 16ab0ebf-7a8e-4824-8ca6-fec5f43619c6 38 fields · synced May 27, 2026