Eustachi Ear Pressure Relief Device
FDA 510(k) clearance K203754 · decided 2021-02-19
Clearance details
- K-number
- K203754
- Device name
- Eustachi Ear Pressure Relief Device
- Applicant
- Exercore, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-12-23
- Decision date
- 2021-02-19
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- MJV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Shakopee, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Earflo (EF001) (K252751) | Earflo, Inc. | 2026-02-10 |
| Ear Pressure Relief Device(Model:ER813B) (K230502) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 |
| EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 (K073401) | Micromedics, Inc. | 2008-03-14 |
| EARCLEAR (K951596) | Arisil Medical | 1995-05-24 |
| OTOVENT (K920840) | Abigo Medical AB | 1992-10-05 |
Recalls involving this device
No recalls on record reference this clearance.