Phoenix EEG Amplifier A404
Phoenix EEG Amplifier A404 is a Class II device made by Southeast Signal, Inc, cleared under FDA 510(k) K071661 on 5 Sep 2007 and listed in FDA GUDID since 29 Dec 2017 (UDI-DI B58804E0), 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 | NumberB58804E0 | Date29 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071661 | Date5 Sep 2007 | StatusActive |
Official records
- FDA 510(k) database K071661
Across registries
- FDA 510(k) K071661 decided 5 Sep 2007 Active
- FDA GUDID UDI-DI B58804E0 listed 29 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K071661
- Listed FDA GUDID B58804E0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phoenix EEG Amplifier
- Generic name
- Multiple physiological signal amplifier
- Model / reference
- A404
- Primary DI / UDI-DI
- B58804E0
- 510(k) Number
- FDA product code
- HCC
- GMDN term
- Multiple physiological signal amplifier
- Device class
- Class II
- Regulation number
- 882.5050
- GUDID distribution status
- In Commercial Distribution
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