The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Ca, Model: Cam.
| Device ID | K071250 |
| 510k Number | K071250 |
| Device Name: | CA, MODEL: CAM |
| Classification | Tomography, Optical Coherence |
| Applicant | OPTOVUE, INC. 41752 CHRISTY STREET Fremont, CA 94538 |
| Contact | Jay Wei |
| Correspondent | Jay Wei OPTOVUE, INC. 41752 CHRISTY STREET 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 | 2007-05-04 |
| Decision Date | 2007-09-28 |
| Summary: | summary |