g.Nautilus PRO 8-Channel
by g.tec medical engineering GmbH
g.Nautilus PRO 8-Channel (5120PRO) is a multiple physiological signal amplifier (FDA Class II) made by g.tec medical engineering GmbH, cleared under FDA 510(k) K171669 on 5 Jul 2017 and listed in FDA GUDID since 23 Nov 2017 (UDI-DI EBCI5120PRO0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberEBCI5120PRO0 | Date23 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171669 | Date5 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K171669
Across registries
- FDA 510(k) K171669 decided 5 Jul 2017 Active
- FDA GUDID UDI-DI EBCI5120PRO0 listed 23 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K171669
- Listed FDA GUDID EBCI5120PRO0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- g.Nautilus PRO
- Generic name
- Multiple physiological signal amplifier
- Model / Ref / Catalog
- 8-Channel, 5120PRO
- Primary DI / UDI-DI
- EBCI5120PRO0
- 510(k) Number
- FDA product code
- GWL, GXY
- GMDN term
- Multiple physiological signal amplifier
- Device class
- Class II
- Regulation number
- 882.1835, 882.1320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).
- NICOLET WIRELESS EEG by Carefusion 209, Inc.
- NomadAir PMU810 by Neurotronics, LLC
- REFA, PHYSIOLOGICAL AMPLIFIER by Tms International BV
- SENSOR AMPLIFIER by Pro-Tech Services, Inc.
- NEUROPACK II 5100 by NIHON KOHDEN AMERICA, INC.
- BE Plus LTM Amplifier GWI Amplifier by EB Neuro S.p.A.
- PORTI 7 PHYSIOLOGICAL AMPLIFIER by Tms International BV
- Quick-20m by Cgx, LLC
- AMPLIFIER OTRONA, MODEL N3A-EMG by Honeywell, Inc.
- NEUROMETRIX BIOAMPLIFIER by NEUROMETRIX, INC.