Ear Pressure Relief Device(Model:ER813B)
FDA 510(k) clearance K230502 · decided 2023-06-09
Clearance details
- K-number
- K230502
- Device name
- Ear Pressure Relief Device(Model:ER813B)
- Applicant
- Ningbo Albert Novosino Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-24
- Decision date
- 2023-06-09
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- MJV
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Yuyao, CN
- 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 |
| Eustachi Ear Pressure Relief Device (K203754) | Exercore, LLC | 2021-02-19 |
| 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.