IVue

Tomography, Optical Coherence

Optovue, Inc.

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

Pre-market Notification Details

• Device ID: K163475
• 510k Number: K163475
• Device Name: IVue
• Classification: Tomography, Optical Coherence
• Applicant: Optovue, Inc. 2800 Bayview Drive Fremont, CA 94538
• Contact: Edward J. Sinclair
• Correspondent: Edward J. Sinclair; Optovue, Inc. 2800 Bayview Drive Fremont, CA 94538
• Product Code: OBO
• CFR Regulation Number: 886.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-12
• Decision Date: 2017-06-09
• Summary: summary