SmartTrOAE Software M814000
by Intelligent Hearing Systems Corp.
SmartTrOAE Software M814000 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K023859 on 8 Jan 2003 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817020020860), 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 | Number00817020020860 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023859 | Date8 Jan 2003 | StatusActive |
Official records
- AccessGUDID record 00817020020860
- FDA 510(k) database K023859
Across registries
- FDA 510(k) K023859 decided 8 Jan 2003 Active
- FDA GUDID UDI-DI 00817020020860 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K023859
- Listed FDA GUDID 00817020020860
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SmartTrOAE Software
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- M814000
- Primary DI / UDI-DI
- 00817020020860
- 510(k) Number
- FDA product code
- EWO
- GMDN term
- Bioelectrical signal analysis software
- Device class
- Class II
- Regulation number
- 874.1050
- GUDID distribution status
- In Commercial Distribution