ECHO-SCREEN

Audiometer

FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Fischer-zoth Audiologic Systems, Inc. with the FDA for Echo-screen.

Pre-market Notification Details

• Device ID: K982642
• 510k Number: K982642
• Device Name: ECHO-SCREEN
• Classification: Audiometer
• Applicant: FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. 11309 BRANDON PARK DR., #B Sandy, UT 84092
• Contact: David G Wood
• Correspondent: David G Wood; FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. 11309 BRANDON PARK DR., #B Sandy, UT 84092
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-29
• Decision Date: 1998-10-21
• Summary: summary