G.usbamp
by g.tec medical engineering GmbH
510(k) K060803
G.usbamp is a medical device (FDA Class II; FDA product code GWL, Amplifier, Physiological Signal) made by g.tec medical engineering GmbH, cleared under FDA 510(k) K060803 on 2 May 2006, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060803 | Date2 May 2006 | StatusActive |
Official records
- FDA 510(k) database K060803
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GWL
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1835
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K060803
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.USBamp USB Biosignal Amplifier | 0216 / USB Biosignal Amplifier | EBCI02160 | — | No longer on the market |
| g.USBamp USB Biosignal Amplifier | 0216US / USB Biosignal Amplifier | EBCI0216US0 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).
- 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.
- NIC36 AMPLIFIER by EB Neuro S.p.A.
- Trackit T4A 1600 by LIFELINES LIMITED
- THE WONDER BOX by Micro Tronics Corp.
- SomniCheck by Brainmatterz, LLC
- DreamClear by Somnomed Technologies Inc., Doing Business AS Remware