The following data is part of a premarket notification filed by Clarity Medical Systems with the FDA for Retcam 3 Ophthalmic Imaging System.
| Device ID | K081858 |
| 510k Number | K081858 |
| Device Name: | RETCAM 3 OPHTHALMIC IMAGING SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 Pleasanton, CA 94588 -4084 |
| Contact | Gary A Seeger |
| Correspondent | Gary A Seeger CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 Pleasanton, CA 94588 -4084 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-01 |
| Decision Date | 2008-11-05 |