The following data is part of a premarket notification filed by Paramed Srl with the FDA for Mrj Extended.
| Device ID | K080098 |
| 510k Number | K080098 |
| Device Name: | MRJ EXTENDED |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PARAMED SRL 39 HIGH STREET North Andover, MA 01845 |
| Contact | Michael A Douglas |
| Correspondent | Michael A Douglas PARAMED SRL 39 HIGH STREET North Andover, MA 01845 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-03-10 |
| Summary: | summary |