External Talk Through Microphone M025550
by Intelligent Hearing Systems Corp.
External Talk Through Microphone M025550 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K900096 on 31 May 1990 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817020020372), 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 | Number00817020020372 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK900096 | Date31 May 1990 | StatusActive |
Official records
- AccessGUDID record 00817020020372
- FDA 510(k) database K900096
Across registries
- FDA 510(k) K900096 decided 31 May 1990 Active
- FDA GUDID UDI-DI 00817020020372 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K900096
- Listed FDA GUDID 00817020020372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- External Talk Through Microphone
- Generic name
- Freestanding microphone
- Model / reference
- M025550
- Primary DI / UDI-DI
- 00817020020372
- 510(k) Number
- FDA product code
- EWO
- GMDN term
- Freestanding microphone
- Device class
- Class II
- Regulation number
- 874.1050
- GUDID distribution status
- In Commercial Distribution
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