The following data is part of a premarket notification filed by Repro-medical System, Inc., Dba Koru Medical Systems with the FDA for Freedomedge Syringe Infusion System.
| Device ID | K214045 |
| 510k Number | K214045 |
| Device Name: | FreedomEdge Syringe Infusion System |
| Classification | Pump, Infusion |
| Applicant | Repro-Medical System, Inc., Dba Koru Medical Systems 24 Carpenter Road Chester, NY 10918 |
| Contact | Christopher Pazdan |
| Correspondent | Kachi Enyinna 510K Technology Group LLC 17 Orchard Terrace East Arlington, MA 02474 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | PKP |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-04-29 |