The following data is part of a premarket notification filed by Midwest Ophthalmic Instruments, Inc. with the FDA for Orims Digital Angiography System.
| Device ID | K952480 |
| 510k Number | K952480 |
| Device Name: | ORIMS DIGITAL ANGIOGRAPHY SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | MIDWEST OPHTHALMIC INSTRUMENTS, INC. 1237 NAPERVILLE DR. Romeoville, IL 60441 |
| Contact | James J Urban |
| Correspondent | James J Urban MIDWEST OPHTHALMIC INSTRUMENTS, INC. 1237 NAPERVILLE DR. Romeoville, IL 60441 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-30 |
| Decision Date | 1995-08-25 |