g.HIamp
by g.tec medical engineering GmbH
510(k) K123255
g.HIamp 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) K123255 on 20 Dec 2012, active as of 12 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 | NumberK123255 | Date20 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K123255
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- Withdrawn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 K123255
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.HIamp 144-Channel Amplifier | 7002 / 144-Channel Amplifier | EBCI7002US0 | — | On the market |
| g.HIamp 144-Channel Amplifier | 7002 / 144-Channel Amplifier | EBCI70020 | — | No longer on the market |
| g.HIamp 16-Channel Amplifier | 7092US / 16-Channel Amplifier | EBCI7092US0 | — | On the market |
| g.HIamp 256-Channel Amplifier | 7003 / 256-Channel Amplifier | EBCI7003US0 | — | On the market |
| g.HIamp 256-Channel Amplifier | 7003 / 256-Channel Amplifier | EBCI70030 | — | No longer on the market |
| g.HIamp 32-Channel Amplifier | 7091US / 32-Channel Amplifier | EBCI7091US0 | — | On the market |
| g.HIamp 80-Channel Amplifier | 7001 / 80-Channel Amplifier | EBCI7001US0 | — | On the market |
| g.HIamp 80-Channel Amplifier | 7001 / 80-Channel Amplifier | EBCI70010 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).
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