Otodynamics

Device Name

Otoport Flexi

Model / Reference

FLX-S

Primary DI / UDI-DI

05060396171208

Basic UDI-DI

B-05060396171208

EMDN Code

Z12149001 Otoacoustic emissions equipment

Device Class

Class IIa

Market of Registration

Germany

EUDAMED SRN

GB-MF-000018964

Authorised representative

MDSS GmbH DE-AR-000005430

• Otodynamics

  Class IIa

  CE/MDD

• ILO2088 Enchocheck or ILO2088 Otocheck

  Class II

  FDA 510(k) K983352 Active Cleared 11 Dec 1998

• ILO88. Otodynamic Analyser, Kit System for Pc

  Class II

  FDA 510(k) K962995 Active Cleared 10 Jan 1997

• Otoport Pro

  Class II

  FDA 510(k) K240430 Active Cleared 15 Mar 2024

• ILO292 Dp Echoport Plus Oae System

  Class II

  FDA 510(k) K983350 Active Cleared 11 Dec 1998

• Otoport

  Class II

  CE/MDD FDA 510(k) K072033 Active Cleared 13 Nov 2007

See all devices from Otodynamics, Ltd. →