The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for R T Vue With Software 5.0 Model: R I Vue 100.
| Device ID | K100861 |
| 510k Number | K100861 |
| Device Name: | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-06-17 |
| Summary: | summary |