The following data is part of a premarket notification filed by Eyequick.llc with the FDA for Vista Digital Opthalmoscope.
| Device ID | K102412 |
| 510k Number | K102412 |
| Device Name: | VISTA DIGITAL OPTHALMOSCOPE |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | EYEQUICK.LLC 1400 COMMON DRIVE El Paso,tx, TX 79936 |
| Contact | Marc Ellman Md |
| Correspondent | Marc Ellman Md EYEQUICK.LLC 1400 COMMON DRIVE El Paso,tx, TX 79936 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-24 |
| Decision Date | 2011-06-23 |
| Summary: | summary |