QScreen

Stimulator, Auditory, Evoked Response

PATH MEDICAL GmbH

The following data is part of a premarket notification filed by Path Medical Gmbh with the FDA for Qscreen.

Pre-market Notification Details

• Device ID: K220139
• 510k Number: K220139
• Device Name: QScreen
• Classification: Stimulator, Auditory, Evoked Response
• Applicant: PATH MEDICAL GmbH Landsberger Strasse 65 Germering, DE 82110
• Contact: Johann Oswald
• Correspondent: Johann Oswald; PATH MEDICAL GmbH Landsberger Strasse 65 Germering, DE 82110
• Product Code: GWJ
• CFR Regulation Number: 882.1900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-01-18
• Decision Date: 2022-08-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260223145889	K220139	000
04260223146312	K220139	000
04260223146305	K220139	000
04260223146299	K220139	000
04260223146282	K220139	000
04260223146275	K220139	000
04260223146268	K220139	000
04260223146251	K220139	000
04260223147302	K220139	000
04260223147296	K220139	000
04260223147289	K220139	000
04260223146329	K220139	000
04260223146336	K220139	000
04260223146343	K220139	000
04260223145766	K220139	000
04260223146725	K220139	000
04260223146688	K220139	000
04260223146671	K220139	000
04260223146664	K220139	000
04260223146657	K220139	000
04260223146565	K220139	000
04260223146558	K220139	000
04260223146541	K220139	000
04260223146534	K220139	000
04260223147272	K220139	000