g.HIamp 32-Channel Amplifier
by g.tec medical engineering GmbH
g.HIamp 32-Channel Amplifier (7091US) is a multiple physiological signal amplifier (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 and listed in FDA GUDID since 30 Mar 2020 (UDI-DI EBCI7091US0), 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 | NumberEBCI7091US0 | Date30 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123255 | Date20 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K123255
Across registries
- FDA 510(k) K123255 decided 20 Dec 2012 Active
- FDA GUDID UDI-DI EBCI7091US0 listed 30 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K123255
- Listed FDA GUDID EBCI7091US0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- g.HIamp
- Generic name
- Multiple physiological signal amplifier
- Model / Ref / Catalog
- 32-Channel Amplifier, 7091US
- Primary DI / UDI-DI
- EBCI7091US0
- 510(k) Number
- FDA product code
- GWL
- GMDN term
- Multiple physiological signal amplifier
- Device class
- Class II
- Regulation number
- 882.1835
- GUDID distribution status
- In Commercial Distribution
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