The following data is part of a premarket notification filed by B. Braun Melsugen Ag with the FDA for Spacestation Mri.
| Device ID | K191910 |
| 510k Number | K191910 |
| Device Name: | SpaceStation MRI |
| Classification | Accessories, Pump, Infusion |
| Applicant | B. Braun Melsugen AG Carl-Braun-Strasse 1 Melsungen, DE 34212 |
| Contact | Ullrich Trottier |
| Correspondent | Andre Kindsvater Emergo Global Consulting , LLC 2500 Bee Cave Road Austin, TX 78746 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-17 |
| Decision Date | 2020-03-12 |