g.Nautilus PRO
by g.tec medical engineering GmbH
510(k) K171669
g.Nautilus PRO 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 EBCI5211PRO0), active as of 9 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 GUDID | NumberEBCI5211PRO0 | Date23 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | 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 EBCI5211PRO0 listed 23 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K171669
- Listed FDA GUDID EBCI5211PRO0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Multiple physiological signal amplifier
- Model / Ref / Catalog
- 16-Channel-mB Sahara, 5211PRO
- Primary DI / UDI-DI
- EBCI5211PRO0
- 510(k) Number
- FDA product code
- GWL, GXY
- GMDN term
- Multiple physiological signal amplifier
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1835 510(k)GUDID882.1320 GUDID
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
Devices cleared under K171669
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| g.Nautilus PRO 16 FLEXIBLE channels | 5710PRO / 16 FLEXIBLE channels | EBCI5710PRO0 | — | On the market |
| g.Nautilus PRO 16-Channel | 5110PRO / 16-Channel | EBCI5110PRO0 | — | On the market |
| g.Nautilus PRO 16-Channel Sahara | 5210PRO / 16-Channel Sahara | EBCI5210PRO0 | — | On the market |
| g.Nautilus PRO 16-Channel-mB | 5111PRO / 16-Channel-mB | EBCI5111PRO0 | — | On the market |
| g.Nautilus PRO 16-Channel-mB Sahara | 5211PRO / 16-Channel-mB Sahara | EBCI5211PRO0 | — | On the market |
| g.Nautilus PRO 16-Channel-rX | 5112PRO / 16-Channel-rX | EBCI5112PRO0 | — | On the market |
| g.Nautilus PRO 16-Channel-rX Sahara | 5212PRO / 16-Channel-rX Sahara | EBCI5212PRO0 | — | On the market |
| g.Nautilus PRO 19 FLEXIBLE channels | 5730PRO / 19 FLEXIBLE channels | EBCI5730PRO0 | — | On the market |
| g.Nautilus PRO 32 FLEXIBLE channels | 5700PRO / 32 FLEXIBLE channels | EBCI5700PRO0 | — | On the market |
| g.Nautilus PRO 32-Channel | 5100PRO / 32-Channel | EBCI5100PRO0 | — | On the market |
| g.Nautilus PRO 32-Channel Sahara | 5200PRO / 32-Channel Sahara | EBCI5200PRO0 | — | On the market |
| g.Nautilus PRO 32-Channel-CSP | 5101PRO / 32-Channel-CSP | EBCI5101PRO0 | — | On the market |
| g.Nautilus PRO 32-Channel-CSP Sahara | 5201PRO / 32-Channel-CSP Sahara | EBCI5201PRO0 | — | On the market |
| g.Nautilus PRO 8 FLEXIBLE channels | 5720PRO / 8 FLEXIBLE channels | EBCI5720PRO0 | — | On the market |
| g.Nautilus PRO 8-Channel | 5120PRO / 8-Channel | EBCI5120PRO0 | — | On the market |
| g.Nautilus PRO 8-Channel Sahara | 5220PRO / 8-Channel Sahara | EBCI5220PRO0 | — | On the market |
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Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).
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- PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER by Professional Health Technologies, Inc.
- Preamplifier Model 113 by Princeton Applied Research Corp.