Nexxis OR

Display, Cathode-ray Tube, Medical

Barco N.v.

The following data is part of a premarket notification filed by Barco N.v. with the FDA for Nexxis Or.

Pre-market Notification Details

• Device ID: K173381
• 510k Number: K173381
• Device Name: Nexxis OR
• Classification: Display, Cathode-ray Tube, Medical
• Applicant: Barco N.v. Beneluxpark 21 Kortrijk, BE 8500
• Contact: Eric Caus
• Correspondent: Eric Caus; Barco N.v. Beneluxpark 21 Kortrijk, BE 8500
• Product Code: DXJ
• CFR Regulation Number: 870.2450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-30
• Decision Date: 2018-02-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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