The following data is part of a premarket notification filed by Repro-med Systems, Inc., Dba Koru Medical Systems with the FDA for Freedom Integrated Syringe Infusion System.
| Device ID | K200176 |
| 510k Number | K200176 |
| Device Name: | FREEDOM Integrated Syringe Infusion System |
| Classification | Pump, Infusion |
| Applicant | Repro-Med Systems, Inc., Dba KORU Medical Systems 24 Carpenter Road Chester, NY 10918 |
| Contact | Cynthia Lacatena |
| Correspondent | Kachi Enyinna Repro-Med Systems, Inc., Dba KORU Medical Systems 24 Carpenter Road Chester, NY 10918 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-24 |
| Decision Date | 2021-12-15 |