The following data is part of a premarket notification filed by Bioptigen, Inc. with the FDA for Bioptigen Spectral Domain Ophthalmic Imaging System.
| Device ID | K063343 |
| 510k Number | K063343 |
| Device Name: | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | BIOPTIGEN, INC. 719 A ST. NE Washington, DC 20002 |
| Contact | Russell Pagano |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2006-12-13 |
| Summary: | summary |