Titan
by Interacoustics A/S 3 variants
510(k) K130795
Titan is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Interacoustics A/S, cleared under FDA 510(k) K130795 on 20 Jun 2013, 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 | FDA 510(k)SESE | NumberK130795 | Date20 Jun 2013 | StatusActive |
Official records
- FDA 510(k) database K130795
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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