The following data is part of a premarket notification filed by Mrp Group, Inc. with the FDA for Ophthavision Imaging System.
| Device ID | K980295 |
| 510k Number | K980295 |
| Device Name: | OPHTHAVISION IMAGING SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | MRP GROUP, INC. 1111 WEST LOWELL AVE. Haverhill, MA 01832 |
| Contact | Matthew Carnevale |
| Correspondent | Matthew Carnevale MRP GROUP, INC. 1111 WEST LOWELL AVE. Haverhill, MA 01832 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-27 |
| Decision Date | 1998-05-19 |
| Summary: | summary |