TITAN

Tester, Auditory Impedance

INTERACOUSTICS A/S

The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Titan.

Pre-market Notification Details

• Device ID: K121847
• 510k Number: K121847
• Device Name: TITAN
• Classification: Tester, Auditory Impedance
• Applicant: INTERACOUSTICS A/S DREJERVAENGET 8 Assens, DK Dk-5610
• Contact: Erik Nielsen
• Correspondent: Erik Nielsen; INTERACOUSTICS A/S DREJERVAENGET 8 Assens, DK Dk-5610
• Product Code: ETY
• CFR Regulation Number: 874.1090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-25
• Decision Date: 2012-11-29
• Summary: summary