ISTAND

Ophthalmoscope, Ac-powered

OPTOVUE, INC.

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

Pre-market Notification Details

• Device ID: K103266
• 510k Number: K103266
• Device Name: ISTAND
• Classification: Ophthalmoscope, Ac-powered
• Applicant: OPTOVUE, INC. 45531 NORTHPORT LOOP W. Fremont, CA 94538
• Contact: John J Talarico
• Correspondent: John J Talarico; OPTOVUE, INC. 45531 NORTHPORT LOOP W. Fremont, CA 94538
• Product Code: HLI
• CFR Regulation Number: 886.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-04
• Decision Date: 2011-06-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858848006285	K103266	000