micromed SystemPlus EVOLUTION
micromed SystemPlus EVOLUTION is a Class II device made by Micromed, Inc., cleared under FDA 510(k) K000963 on 20 Oct 2000 and listed in FDA GUDID since 21 Mar 2018 (UDI-DI 08033928120880), 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 | Number08033928120880 | Date21 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000963 | Date20 Oct 2000 | StatusActive |
Official records
- AccessGUDID record 08033928120880
- FDA 510(k) database K000963
Across registries
- FDA 510(k) K000963 decided 20 Oct 2000 Active
- FDA GUDID UDI-DI 08033928120880 listed 21 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K000963
- Listed FDA GUDID 08033928120880
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- micromed
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- SystemPlus EVOLUTION
- Description
- software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG)
- Primary DI / UDI-DI
- 08033928120880
- 510(k) Number
- FDA product code
- GWE, OLT, GWF, GWQ
- GMDN term
- Bioelectrical signal analysis software
- Device class
- Class II
- Regulation number
- 882.1890, 882.1400, 882.1870
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWE (Stimulator, Photic, Evoked Response).
- Modified Brain Atlas III by Bio-Logic Systems Corp.
- LED PHOTIC System by Micromed S.p.A.
- Wave Gate by Wolfline Corp.
- Teca Neuropto With OS-5 Stimulator by Teca, Inc.
- SLS 3500 LED Visual Stimulator by NIHON KOHDEN AMERICA, INC.
- Tomey PE-400 Portable ERG & VEP With Optional PS-4 by Tomey Corporation USA
- Model S10VS Visual Stimulator by Grass Instrument Co.
- VISIONSEARCH 1 by Visionsearch Pty, Ltd.
- EVOKED POTENTIAL SYSTEM 2000 by Ophthalmetric Corp.
- MACULOSCOPE(TM) by Doran Instruments, Inc.