OTOVENT

Device, Inflation, Middle Ear

ABIGO MEDICAL AB

The following data is part of a premarket notification filed by Abigo Medical Ab with the FDA for Otovent.

Pre-market Notification Details

• Device ID: K920840
• 510k Number: K920840
• Device Name: OTOVENT
• Classification: Device, Inflation, Middle Ear
• Applicant: ABIGO MEDICAL AB DATAVAGEN 23, S-436 32 ASKIM S-436 32 ASKIM Sweden, SE
• Contact: Jan G Smith
• Correspondent: Jan G Smith; ABIGO MEDICAL AB DATAVAGEN 23, S-436 32 ASKIM S-436 32 ASKIM Sweden, SE
• Product Code: MJV
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-02-24
• Decision Date: 1992-10-05