CALLISTO EYE

System, Image Management, Ophthalmic

CARL ZEISS MEDITEC AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Callisto Eye.

Pre-market Notification Details

• Device ID: K123464
• 510k Number: K123464
• Device Name: CALLISTO EYE
• Classification: System, Image Management, Ophthalmic
• Applicant: CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568
• Contact: Judy Brimacombe
• Correspondent: Judy Brimacombe; CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568
• Product Code: NFJ
• Subsequent Product Code: EPT
• Subsequent Product Code: HMR
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-09
• Decision Date: 2013-03-05
• Summary: summary