510(k) K211206
K211206 is an FDA 510(k) premarket notification submitted by Repro-Medical System, Inc., Dba Koru Medical Systems for the device "FreedomEdge(R) Syringe Infusion System". The FDA issued a decision of Substantially Equivalent on Nov 9, 2021. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Repro-Medical System, Inc., Dba Koru Medical Systems has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 2021
- Date Received
- Apr 22, 2021
- 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
- 510(k)