The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Ivue, Model 100.
| Device ID | K091404 |
| 510k Number | K091404 |
| Device Name: | IVUE, MODEL 100 |
| Classification | Tomography, Optical Coherence |
| 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 | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-12 |
| Decision Date | 2010-04-22 |
| Summary: | summary |