The following data is part of a premarket notification filed by Asg Superconductors S.p.a. with the FDA for Mropen Evo.
| Device ID | K193116 |
| 510k Number | K193116 |
| Device Name: | MRopen EVO |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ASG Superconductors S.p.A. Corso Ferdinando Maria Perrone 73/R Genova, IT 16152 |
| Contact | Debenedetti Luisella |
| Correspondent | Luisella De Benedetti ASG Superconductors S.p.A. Corso Ferdinando Maria Perrone 73/R Genova, IT 16152 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5450320000040 | K193116 | 000 |