Phoenix EEG Amplifier A202
Phoenix EEG Amplifier A202 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 B58802E0), 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 | NumberB58802E0 | 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 B58802E0 listed 29 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K071661
- Listed FDA GUDID B58802E0
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- Withdrawn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
- A202
- Primary DI / UDI-DI
- B58802E0
- 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
Similar devices
Other devices filed under FDA product code HCC (Device, Biofeedback).
- TT-EEG LINKED EAR ATTACHMENT KIT T8755 by Thought Technology Ltd.
- TEMPERATURE 132 by Calnor of EL Paseo, Inc.
- V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU by Nebulae Productions
- M424 EMG MONITOR by Bio-Logic Devices
- STRESS CONTROL BIOFEEDBACK CARD by Pilgrim Plastic Products Co.
- FEEDBACK EMG SYSTEM PE-020 by Bio-Feedback Systems, Inc.
- PARO Robot MCR-900 UC White V9-14UC by INTELLIGENT SYSTEMS CO LTD
- ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM by Eclosion, Inc.
- EEGER4 MODEL 4.3 by Eeg Software, LLC
- THE BAGNOLI-8 EMG SYSTEM by DELSYS, INC.