FDA 510(k)
FDA unclassified
Substantially Equivalent
🇸🇪 Sweden
OTOVENT
K Number: K920840
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
5
Applicant Total
5
Review Days
224
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Basic Information
- Device Name
- OTOVENT
- K Number
- K920840
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abigo Medical AB
- Date Received
- February 24, 1992
- Decision Date
- October 5, 1992
- Product Code
- MJV
- Advisory Committee
- Unknown
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MJV | Device, Inflation, Middle Ear | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MJV), ordered by most recent decision date.
Earflo (EF001)
FDA 510(k)
FDA Unclassified
·Unknown
Ear Pressure Relief Device(Model:ER813B)
FDA 510(k)
FDA Unclassified
·Unknown
Eustachi Ear Pressure Relief Device
FDA 510(k)
FDA Unclassified
·Unknown
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
FDA 510(k)
FDA Unclassified
·Unknown
EARCLEAR
FDA 510(k)
FDA Unclassified
·Unknown
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|---|---|---|---|
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | Aug 21, 2017 | Substantially Equivalent |
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Jul 1, 2016 | Substantially Equivalent |
| K100591 | SORBACT | Jan 24, 2011 | Substantially Equivalent |
| K063059 | SORBACT WOUND DRESSING | Apr 19, 2007 | Substantially Equivalent |