IVUE WITH NORMATIVE DATABASE

Ophthalmoscope, Ac-powered

OPTOVUE, INC.

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

Pre-market Notification Details

• Device ID: K121739
• 510k Number: K121739
• Device Name: IVUE WITH NORMATIVE DATABASE
• Classification: Ophthalmoscope, Ac-powered
• Applicant: OPTOVUE, INC. 45531 Northport Loop W Fremont, CA 94538
• Contact: Azimun Jamal
• Correspondent: Azimun Jamal; 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: 2012-06-13
• Decision Date: 2013-01-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858848006612	K121739	000
00858848006148	K121739	000
00858848006131	K121739	000
00858848006124	K121739	000
00858848006117	K121739	000
00858848006100	K121739	000
00858848006094	K121739	000
00858848006087	K121739	000
00858848006070	K121739	000
00858848006063	K121739	000
00858848006056	K121739	000
00858848006049	K121739	000
00858848006155	K121739	000
00858848006162	K121739	000
00858848006605	K121739	000
00858848006568	K121739	000
00858848006551	K121739	000
00858848006544	K121739	000
00858848006537	K121739	000
00858848006506	K121739	000
00858848006490	K121739	000
00858848006483	K121739	000
00858848006476	K121739	000
00858848006223	K121739	000
00858848006216	K121739	000
00858848006773	K121739	000