DPOAE20, Eclipse
510(k) K060539
DPOAE20, Eclipse is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Interacoustics A/S, Assens, cleared under FDA 510(k) K060539 on 30 May 2006, active as of 25 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 | NumberK060539 | Date30 May 2006 | StatusActive |
Official records
- FDA 510(k) database K060539
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- Withdrawn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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