FreedomEdge Syringe Infusion System— 510(k) K214045
Substantially EquivalentRepro-Medical System, Inc., Dba Koru Medical Systems
FDA 510(k) clearance K214045 for FreedomEdge Syringe Infusion System, Substantially Equivalent on 2022-04-29. Applicant: Repro-Medical System, Inc., Dba Koru Medical Systems. Device class: 2.
Clearance details
- Applicant
- Repro-Medical System, Inc., Dba Koru Medical Systems
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code FRN
view all- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
More clearances from Repro-Medical System, Inc., Dba Koru Medical Systems
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.