Sera

Audiometer

Interacoustics A/S

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

Pre-market Notification Details

• Device ID: K173567
• 510k Number: K173567
• Device Name: Sera
• Classification: Audiometer
• Applicant: Interacoustics A/S Audiometer Alle 1 Middelfart, DK 5500
• Contact: Amy Yanta
• Correspondent: Amy Yanta; Interacoustics A/S Audiometer Alle 1 Middelfart, DK 5500
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-20
• Decision Date: 2018-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05711117190823	K173567	000