SpaceStation MRI
FDA 510(k) clearance K191910 · decided 2020-03-12
Clearance details
- K-number
- K191910
- Device name
- SpaceStation MRI
- Applicant
- B. Braun Melsugen AG
- Decision
- Substantially Equivalent
- Date received
- 2019-07-17
- Decision date
- 2020-03-12
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Melsungen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U recall (Z-2972-2024) | B Braun Medical Inc | 2024-09-07 |
| Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog recall (Z-2433-2024) | B Braun Medical Inc | 2024-07-25 |
| Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catal recall (Z-2434-2024) | B Braun Medical Inc | 2024-07-25 |
| Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8 recall (Z-2435-2024) | B Braun Medical Inc | 2024-07-25 |
| Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/C recall (Z-2437-2024) | B Braun Medical Inc | 2024-07-25 |
| 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System recall (Z-0123-2024) | B. Braun Medical, Inc. | 2023-10-25 |
| 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump recall (Z-0124-2024) | B. Braun Medical, Inc. | 2023-10-25 |