PreOp

Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Epilog

The following data is part of a premarket notification filed by Epilog with the FDA for Preop.

Pre-market Notification Details

• Device ID: K172858
• 510k Number: K172858
• Device Name: PreOp
• Classification: Source Localization Software For Electroencephalograph Or Magnetoencephalograph
• Applicant: Epilog Vlasgaardstraat 52 Ghent, BE 9000
• Contact: Gregor Strobbe
• Correspondent: Patsy Trisler; Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, MD 20815
• Product Code: OLX
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-20
• Decision Date: 2018-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05430000733021	K172858	000
05430000733045	K172858	000