510(k) K242735
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) by
Belmont Medical Technologies
— Product Code FRN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2024
- Date Received
- September 11, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type