Otogram ML4000
Otogram ML4000 is a Class II device made by Ototronix, LLC, cleared under FDA 510(k) K070118 on 7 Mar 2007 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI M737ML40001), 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 | NumberM737ML40001 | Date13 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070118 | Date7 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K070118
Across registries
- FDA 510(k) K070118 decided 7 Mar 2007 Active
- FDA GUDID UDI-DI M737ML40001 listed 13 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K070118
- Listed FDA GUDID M737ML40001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Otogram
- Generic name
- Tone audiometer, automated
- Model / reference
- ML4000
- Primary DI / UDI-DI
- M737ML40001
- 510(k) Number
- FDA product code
- EWO
- GMDN term
- Tone audiometer, automated
- Device class
- Class II
- Regulation number
- 874.1050
- GUDID distribution status
- In Commercial Distribution
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