VISUCAM

Device, Storage, Images, Ophthalmic

CARL ZEISS OPHTHALMIC SYSTEMS, INC.

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

Pre-market Notification Details

• Device ID: K021787
• 510k Number: K021787
• Device Name: VISUCAM
• Classification: Device, Storage, Images, Ophthalmic
• Applicant: CARL ZEISS OPHTHALMIC SYSTEMS, INC. 555 THIREENTH STREET, N.W. Washington, DC 20004 -1109
• Contact: Dionne N Labatore
• Correspondent: Dionne N Labatore; CARL ZEISS OPHTHALMIC SYSTEMS, INC. 555 THIREENTH STREET, N.W. Washington, DC 20004 -1109
• Product Code: NFF
• CFR Regulation Number: 892.2010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-30
• Decision Date: 2002-06-21
• Summary: summary