Easyscreen

Audiometer

Maico Diagnostics GmbH

The following data is part of a premarket notification filed by Maico Diagnostics Gmbh with the FDA for Easyscreen.

Pre-market Notification Details

• Device ID: K171506
• 510k Number: K171506
• Device Name: Easyscreen
• Classification: Audiometer
• Applicant: Maico Diagnostics GmbH Sickingenstr. 70-71 Berlin, DE 10553
• Contact: Amy Yanta
• Correspondent: Amy Yanta; Maico Diagnostics GmbH Sickingenstr. 70-71 Berlin, DE 10553
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-23
• Decision Date: 2017-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260176121169	K171506	000