The following data is part of a premarket notification filed by Paramed S.r.l. with the FDA for Mropen.
| Device ID | K151466 |
| 510k Number | K151466 |
| Device Name: | MrOpen |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Paramed S.r.l. Corso F. M. Perrone 73R Genoa, IT 16152 |
| Contact | Luisella De Benedetti |
| Correspondent | Luisella De Benedetti Paramed S.r.l. Corso F. M. Perrone 73R Genoa, IT 16152 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B545032000000 | K151466 | 000 |