510(k) K050301
K050301 is an FDA 510(k) premarket notification submitted by Iradimed Corporation for the device "MRIDIUM 3850 MRI PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Iradimed Corporation has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 2005
- Date Received
- February 8, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type