AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

Audiometer

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Audx Pro Otoacoustic Emissions Measurement System.

Pre-market Notification Details

• Device ID: K122496
• 510k Number: K122496
• Device Name: AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
• Classification: Audiometer
• Applicant: BIO-LOGIC SYSTEMS CORP. ONE BIOLOGIC PLAZA Mundelein, IL 60060
• Contact: Timothy Karlovsky
• Correspondent: Timothy Karlovsky; BIO-LOGIC SYSTEMS CORP. ONE BIOLOGIC PLAZA Mundelein, IL 60060
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-16
• Decision Date: 2012-11-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382830055130	K122496	000
00382830055093	K122496	000
00382830055055	K122496	000
00382830054454	K122496	000
00382830054447	K122496	000
00382830001595	K122496	000