510(k) K200176
K200176 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. Dba Koru Medical Systems for the device "FREEDOM Integrated Syringe Infusion System". The FDA issued a decision of Substantially Equivalent on Dec 15, 2021. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2021
- Date Received
- Jan 24, 2020
- 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)