FORUM

System, Image Management, Ophthalmic

CARL ZEISS MEDITEC, INC.

The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Forum.

Pre-market Notification Details

• Device ID: K090439
• 510k Number: K090439
• Device Name: FORUM
• Classification: System, Image Management, Ophthalmic
• Applicant: CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin, CA 94568
• Contact: Kent W Jones
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: NFJ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-02-20
• Decision Date: 2009-03-25
• Summary: summary