EXCELSIOR

System, Image Management, Ophthalmic

EYEKOR, LLC.

The following data is part of a premarket notification filed by Eyekor, Llc. with the FDA for Excelsior.

Pre-market Notification Details

• Device ID: K130453
• 510k Number: K130453
• Device Name: EXCELSIOR
• Classification: System, Image Management, Ophthalmic
• Applicant: EYEKOR, LLC. 5 TIMBER LANE North Reading, MA 01864
• Contact: Maureen O'connell
• Correspondent: Maureen O'connell; EYEKOR, LLC. 5 TIMBER LANE North Reading, MA 01864
• Product Code: NFJ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-22
• Decision Date: 2013-04-02
• Summary: summary