The following data is part of a premarket notification filed by Paramed Srl with the FDA for Mropen.
| Device ID | K101295 |
| 510k Number | K101295 |
| Device Name: | MROPEN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PARAMED SRL 39 HIGH STREET North Andover, MA 01845 |
| Contact | Richard R Glasheen |
| Correspondent | Richard R Glasheen 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 | 2010-05-10 |
| Decision Date | 2010-07-28 |
| Summary: | summary |