SmartEP-ASSR Software M811007
by Intelligent Hearing Systems Corp.
SmartEP-ASSR Software M811007 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K031051 on 20 Feb 2004 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817020020815), active as of 22 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 | Number00817020020815 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031051 | Date20 Feb 2004 | StatusActive |
Official records
- AccessGUDID record 00817020020815
- FDA 510(k) database K031051
Across registries
- FDA 510(k) K031051 decided 20 Feb 2004 Active
- FDA GUDID UDI-DI 00817020020815 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K031051
- Listed FDA GUDID 00817020020815
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SmartEP-ASSR Software
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- M811007
- Primary DI / UDI-DI
- 00817020020815
- 510(k) Number
- FDA product code
- GWJ
- GMDN term
- Bioelectrical signal analysis software
- Device class
- Class II
- Regulation number
- 882.1900
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWJ (Stimulator, Auditory, Evoked Response).
- ALGO 7i ATA Cable long 101004 A7i-101004 by PATH medical GmbH
- AURIS AEP by Synapsys, Inc.
- Interacoustics Sera by Interacoustics A/S
- AMPLAID MARK 4 AND MARK 5 by Amplaid USA, Inc.
- SABRE COMPAC by Sle Limited
- EXCEL AV STIM 1000 by Excel Tech., Ltd.
- Ear Tip IT-02 Pack/100 pcs. 100899-100 by PATH medical GmbH
- ISIS 504271 by inomed Medizintechnik GmbH
- ISIS 504285 by inomed Medizintechnik GmbH
- MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM by Bio-Logic Systems Corp.