The following data is part of a premarket notification filed by Coherent Medical Division with the FDA for Coherent Fundusl Retinal Camera.
| Device ID | K822908 |
| 510k Number | K822908 |
| Device Name: | COHERENT FUNDUSL RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | COHERENT MEDICAL DIVISION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-30 |
| Decision Date | 1983-01-05 |