SpaceStation MRI— 510(k) K191910
Substantially EquivalentB. Braun Melsugen AG
FDA 510(k) clearance K191910 for SpaceStation MRI, Substantially Equivalent on 2020-03-12. Applicant: B. Braun Melsugen AG. Device class: 2.
Clearance details
- Applicant
- B. Braun Melsugen AG
- Product code
- Code MRZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melsungen, DE
Recent devices under product code MRZ
view allRecalls naming K191910
K-number listed on FDA's recall record- Z-2972-2024 — Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
- Z-2433-2024 — 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: N/A
- Z-2434-2024 — 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, 1 each Component: N/A
- Z-2435-2024 — 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
- Z-2437-2024 — 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 Component: N/A
- Z-0123-2024 — 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Z-0124-2024 — 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System
- Z-0819-2022 — PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191910.
Data sourced from openFDA. This site is unofficial and independent of the FDA.