The following data is part of a premarket notification filed by Bioptigen, Inc. with the FDA for Envisu Spectral Domain Ophthalmic Imaging System (sdois).
| Device ID | K120057 |
| 510k Number | K120057 |
| Device Name: | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | BIOPTIGEN, INC. 104 T.W. ALEXANDER DRIVE P.O. BOX 13569 Durham, NC 27709 |
| Contact | Dawn Reilly-o'dell |
| Correspondent | Dawn Reilly-o'dell BIOPTIGEN, INC. 104 T.W. ALEXANDER DRIVE P.O. BOX 13569 Durham, NC 27709 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857691006053 | K120057 | 000 |
| 00857691006022 | K120057 | 000 |