510(k) K230502
- Device
- Ear Pressure Relief Device(Model:ER813B)
- Applicant
- Ningbo Albert Novosino Co., Ltd.
- 510(k) number
- K230502
- Product code
- MJV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-09
- Date received
- 2023-02-24
- Classification name
- Device, Inflation, Middle Ear
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Victor Zhou
- Address
- # 28 Yunshan Middle Rd., Sanqishi Town Yuyao CN 315412 315412
FDA Registration Numbers#
- 3021636313
- 3006157842
- 3043739646
- 3021916254
- 3008719017
- 1052728
- 2954718
Source Documents#
Other 510(k) Records For Product Code MJV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252751 | Earflo (EF001) | Earflo, Inc. | 2026-02-10 |
| K203754 | Eustachi Ear Pressure Relief Device | Exercore, LLC | 2021-02-19 |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008-03-14 |
| K951596 | EARCLEAR | Arisil Medical | 1995-05-24 |
| K920840 | OTOVENT | Abigo Medical AB | 1992-10-05 |