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 |