The following data is part of a premarket notification filed by Massie Research Laboratories, Inc. with the FDA for Retcam Ii.
| Device ID | K001275 |
| 510k Number | K001275 |
| Device Name: | RETCAM II |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | MASSIE RESEARCH LABORATORIES, INC. 6761 SIERRA CT., SUITE E Dublin, CA 94568 |
| Contact | Bert Massie |
| Correspondent | Bert Massie MASSIE RESEARCH LABORATORIES, INC. 6761 SIERRA CT., SUITE E Dublin, CA 94568 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-20 |
| Decision Date | 2000-07-13 |