MRidium 3860+ MRI infusion Pump/ Monitoring System
FDA 510(k) clearance K143369 · decided 2016-12-15
Clearance details
- K-number
- K143369
- Device name
- MRidium 3860+ MRI infusion Pump/ Monitoring System
- Applicant
- Iradimed Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-11-25
- Decision date
- 2016-12-15
- Days to decision
- 751 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Winter Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Ada recall (Z-1310-2023) | Iradimed Corporation | 2023-03-30 |