EyeArt
Diabetic Retinopathy Detection Device
Eyenuk, Inc
The following data is part of a premarket notification filed by Eyenuk, Inc with the FDA for Eyeart.
Pre-market Notification Details
| Device ID | K200667 |
| 510k Number | K200667 |
| Device Name: | EyeArt |
| Classification | Diabetic Retinopathy Detection Device |
| Applicant | Eyenuk, Inc 5850 Canoga Ave. Suite 250 Los Angeles, CA 91367 |
| Contact | Kaushal Solanki |
| Correspondent | Kaushal Solanki Eyenuk, Inc 5850 Canoga Ave. Suite 250 Los Angeles, CA 91367 |
| Product Code | PIB |
| CFR Regulation Number | 886.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-08-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000470001 | K200667 | 000 |
Trademark Results [EyeArt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EYEART 87504971 5573046 Live/Registered |
Eyenuk, Inc. 2017-06-26 |
 EYEART 75401143 2224104 Live/Registered |
Lombardi, John L. 1997-12-05 |
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