510(k) K920840
K920840 is an FDA 510(k) premarket notification submitted by Abigo Medical AB for the device "OTOVENT". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code MJV (Device, Inflation, Middle Ear), a Class U device. Abigo Medical AB has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1992
- Date Received
- February 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Inflation, Middle Ear
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type