The following data is part of a premarket notification filed by American Medical Optics with the FDA for Amer. Medical Optic Monocular Direct Ophthalmascop.
| Device ID | K851263 |
| 510k Number | K851263 |
| Device Name: | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | AMERICAN MEDICAL OPTICS 1402 EAST ALTON AVE. Irvine, CA 92714 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky AMERICAN MEDICAL OPTICS 1402 EAST ALTON AVE. Irvine, CA 92714 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-28 |
| Decision Date | 1985-05-01 |