CARA

System, Image Management, Ophthalmic

DIAGNOS, INC

The following data is part of a premarket notification filed by Diagnos, Inc with the FDA for Cara.

Pre-market Notification Details

• Device ID: K110869
• 510k Number: K110869
• Device Name: CARA
• Classification: System, Image Management, Ophthalmic
• Applicant: DIAGNOS, INC 300 BRICKSTONE SQUARE Andover, MA 01810
• Contact: Aron Shapiro
• Correspondent: Aron Shapiro; DIAGNOS, INC 300 BRICKSTONE SQUARE Andover, MA 01810
• Product Code: NFJ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-29
• Decision Date: 2011-07-14
• Summary: summary