Ero Scan Oae Test System
510(k) K010165
Ero Scan Oae Test System is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Etymotic Research, cleared under FDA 510(k) K010165 on 12 Mar 2001, 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 | NumberK010165 | Date12 Mar 2001 | StatusActive |
Official records
- FDA 510(k) database K010165
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- Withdrawn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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