The following data is part of a premarket notification filed by Asg Superconductors S.p.a. with the FDA for Upgrade Kit Mr Gui Pro, Mrj 3300 Plus.
| Device ID | K192690 |
| 510k Number | K192690 |
| Device Name: | Upgrade Kit MR GUI PRO, MrJ 3300 Plus |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ASG Superconductors S.p.A. Corso Ferdinando Maria Perrone 73/R Genova, IT 16152 |
| Contact | De Benedetti Luisella |
| Correspondent | De Benedetti Luisella 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 | 2019-09-26 |
| Decision Date | 2019-10-24 |
| Summary: | summary |