The following data is part of a premarket notification filed by Minami, Tomine & Lew with the FDA for F110 Photo Binocular Ophthalmoscope.
| Device ID | K802351 |
| 510k Number | K802351 |
| Device Name: | F110 PHOTO BINOCULAR OPHTHALMOSCOPE |
| Classification | Pupillometer, Ac-powered |
| Applicant | MINAMI, TOMINE & LEW 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLG |
| CFR Regulation Number | 886.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-25 |
| Decision Date | 1980-12-17 |