Lyra

Audiometer

Interacoustics A/S

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

Pre-market Notification Details

• Device ID: K191372
• 510k Number: K191372
• Device Name: Lyra
• Classification: Audiometer
• Applicant: Interacoustics A/S Audiometer Alle 1 Middelfart, DK Dk-5500
• Contact: Erik Nielsen
• Correspondent: Erik Nielsen; Interacoustics A/S Audiometer Alle 1 Middelfart, DK 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: 2019-05-22
• Decision Date: 2019-07-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05711117196313	K191372	000