510(k) K920840
- Device
- OTOVENT
- Applicant
- ABIGO MEDICAL AB
- 510(k) number
- K920840
- Product code
- MJV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-10-05
- Date received
- 1992-02-24
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Inflation, Middle Ear
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ear Nose & Throat
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAN G SMITH
- Address
- Datavagen 23, S-436 32 Askim S-436 32 Askim Sweden SE
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 |
| 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 |
Legacy Summary#
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FDA Review#
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