The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Ivue 500.
| Device ID | K133892 |
| 510k Number | K133892 |
| Device Name: | IVUE 500 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | OPTOVUE, INC. 2800 BAYVIEW DRIVE Fremont, CA 94538 |
| Contact | Michael J Sarrasin |
| Correspondent | Michael J Sarrasin OPTOVUE, INC. 2800 BAYVIEW DRIVE 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 | 2013-12-20 |
| Decision Date | 2014-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858848006438 | K133892 | 000 |
| 00858848006421 | K133892 | 000 |
| 00858848006407 | K133892 | 000 |
| 00858848006315 | K133892 | 000 |
| 00858848006018 | K133892 | 000 |
| 00858848006742 | K133892 | 000 |
| 00858848006735 | K133892 | 000 |