Avanti
Tomography, Optical Coherence
Optovue, Inc.
The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Avanti.
Pre-market Notification Details
| Device ID | K180660 |
| 510k Number | K180660 |
| Device Name: | Avanti |
| Classification | Tomography, Optical Coherence |
| Applicant | Optovue, Inc. 2800 Bayview Drive Fremont, CA 94538 |
| Contact | Indu Lakshman |
| Correspondent | Indu Lakshman Optovue, Inc. 2800 Bayview Drive 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 | 2018-03-14 |
| Decision Date | 2018-06-08 |
| Summary: | summary |
Trademark Results [Avanti]
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