SmartDPOAE Software M813000
by Intelligent Hearing Systems Corp.
SmartDPOAE Software M813000 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K964426 on 3 Feb 1997 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817020020853), 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 | Number00817020020853 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK964426 | Date3 Feb 1997 | StatusActive |
Official records
- AccessGUDID record 00817020020853
- FDA 510(k) database K964426
Across registries
- FDA 510(k) K964426 decided 3 Feb 1997 Active
- FDA GUDID UDI-DI 00817020020853 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K964426
- Listed FDA GUDID 00817020020853
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SmartDPOAE Software
- Generic name
- Bioelectrical signal analysis software
- Model / reference
- M813000
- Primary DI / UDI-DI
- 00817020020853
- 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
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