510(k) K191910 ยท MRZ Accessories, Pump, Infusion
SpaceStation MRI
| Applicant | B. Braun Melsugen AG, Melsungen, DE |
| Decision | Substantially Equivalent, Mar 12, 2020 |
| Received | Jul 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2024 | B Braun Medical Inc Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U Open, Classified |
FRN | None listed |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Infusion Pump System
Model/Catalog Number: 8713030U
Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each
Component: Open, Classified |
FRN | None listed |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Syringe Pump, Wireless
Model/Catalog Number: 8713031U
Software Version: 8713031U
Product Description: Perfusor Space Syringe Pump, Infusion Pump Open, Classified |
FRN | None listed |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor PCA Syringe Pump
Model/Catalog Number: 8713080U
Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each
Component: N/A Open, Classified |
FRN | None listed |
| Jul 25, 2024 | B Braun Medical Inc Brand Name: Perfusor Space
Product Name: Perfusor Space Syringe Pump, Non-Wireless
Model/Catalog Number: 8713032U
Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each
Open, Classified |
FRN | None listed |
| Oct 25, 2023 | B. Braun Medical, Inc. 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Open, Classified |
FRN | None listed |
| Oct 25, 2023 | B. Braun Medical, Inc. 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System Open, Classified |
FRN | None listed |
| Feb 7, 2022 | B Braun Medical Inc PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions
Catalog Number: 8713030U Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.