TITAN

Stimulator, Auditory, Evoked Response

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: K103760
• 510k Number: K103760
• Device Name: TITAN
• Classification: Stimulator, Auditory, Evoked Response
• 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: GWJ
• CFR Regulation Number: 882.1900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-23
• Decision Date: 2011-05-05
• Summary: summary