Ear Pressure Relief Device(Model:ER813B)
FDA 510(k) K230502 · Ningbo Albert Novosino Co., Ltd.
510(k) numberK230502
Submission
- Device name
- Ear Pressure Relief Device(Model:ER813B)
- Applicant
- Ningbo Albert Novosino Co., Ltd.
Yuyao, CN - Received
- February 24, 2023
- Decision date
- June 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJV – Device, Inflation, Middle Ear
- Device class
- Unclassified
Other 510(k)s with product code MJV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252751 | Earflo (EF001)MJV · Traditional | Earflo, Inc. | 02/10/2026SE |
| K203754 | Eustachi Ear Pressure Relief DeviceMJV · Traditional | Exercore, LLC | 02/19/2021SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | Micromedics, Inc. | 03/14/2008SE |
| K951596 | EarclearMJV · Traditional | Arisil Medical | 05/24/1995SE |
| K920840 | OtoventMJV · Traditional | Abigo Medical AB | 10/05/1992SE |
More from Abigo Medical AB
| 510(k) | Device | Decision |
|---|---|---|
| K173044 | Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffDXQ · Traditional | 11/20/2017SE |
Questions and answers
When was Ear Pressure Relief Device(Model:ER813B) cleared by the FDA?
Ear Pressure Relief Device(Model:ER813B) (K230502) received a 510(k) decision of Substantially Equivalent on June 9, 2023, 105 days after the submission was received.
What is the product code of K230502?
The FDA product code is MJV – Device, Inflation, Middle Ear, a Unclassified device.