The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Rtvue.
| Device ID | K062552 |
| 510k Number | K062552 |
| Device Name: | RTVUE |
| Classification | Tomography, Optical Coherence |
| Applicant | OPTOVUE, INC. 41752 CHRISTY STREET Fremont, CA 94538 |
| Contact | Jay Wei |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2006-10-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RTVUE 77906399 3828247 Dead/Cancelled |
Optovue, Inc. 2010-01-06 |