Oto Wizzard
by Medrx, Inc.
510(k) K981511
Oto Wizzard is a Class II device made by Medrx, Inc., cleared under FDA 510(k) K981511 on 24 Jul 1998, 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 | NumberK981511 | Date24 Jul 1998 | StatusActive |
Official records
- FDA 510(k) database K981511
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- Withdrawn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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