AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

Audiometer

NATUS MEDICAL INCORPORATED

The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Audx Otoacoustic Emissions Measurement System With Audx I/o Function.

Pre-market Notification Details

• Device ID: K111618
• 510k Number: K111618
• Device Name: AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
• Classification: Audiometer
• Applicant: NATUS MEDICAL INCORPORATED 388 MARKET STREET SUITE 1460 San Francisco, CA 94111
• Contact: Charles L Morin
• Correspondent: Charles L Morin; NATUS MEDICAL INCORPORATED 388 MARKET STREET SUITE 1460 San Francisco, CA 94111
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-10
• Decision Date: 2011-12-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382830055048	K111618	000
00382830054980	K111618	000
00382830054973	K111618	000
00382830054959	K111618	000
00382830001588	K111618	000
00382830000840	K111618	000
00382830000833	K111618	000
00382830000789	K111618	000
00382830000734	K111618	000