Cleared Traditional

OTOVENT

K920840 · Abigo Medical AB · Ear, Nose, Throat
Oct 1992
Decision
224d
Days
—
Risk

About This 510(k) Submission

K920840 is an FDA 510(k) clearance for the OTOVENT, a Device, Inflation, Middle Ear, submitted by Abigo Medical AB (Sweden, SE). The FDA issued a Cleared decision on October 5, 1992, 224 days after receiving the submission on February 24, 1992. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number K920840 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1992
Decision Date October 05, 1992
Days to Decision 224 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code MJV — Device, Inflation, Middle Ear
Device Class —