The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Rtvue Xr Oct.
| Device ID | K120238 |
| 510k Number | K120238 |
| Device Name: | RTVUE XR OCT |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-26 |
| Decision Date | 2012-04-03 |
| Summary: | summary |