AUDIT

Audiometer

AXONICS, INC.

The following data is part of a premarket notification filed by Axonics, Inc. with the FDA for Audit.

Pre-market Notification Details

• Device ID: K822335
• 510k Number: K822335
• Device Name: AUDIT
• Classification: Audiometer
• Applicant: AXONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-08-04
• Decision Date: 1983-02-07