510(k) K252751
- Device
- Earflo (EF001)
- Applicant
- Earflo, Inc.
- 510(k) number
- K252751
- Product code
- MJV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-10
- Date received
- 2025-08-29
- 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
- N
Applicant Contact#
- Contact
- Intan Oldakowska
- Address
- 848 Knoll Dr. San Carlos CA US 94070 94070
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 |
|---|---|---|---|
| K230502 | Ear Pressure Relief Device(Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | 2023-06-09 |
| 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 |