The following data is part of a premarket notification filed by Repro-med Systems, Inc., Dba Rms Medical Products with the FDA for Integrated Catch-up Freedom Syringe Driver Infusion System.
| Device ID | K162613 |
| 510k Number | K162613 |
| Device Name: | Integrated Catch-up Freedom Syringe Driver Infusion System |
| Classification | Pump, Infusion |
| Applicant | Repro-Med Systems, Inc., DBA RMS Medical Products 24 Carpenter Road Chester, NY 10918 |
| Contact | Fred Ma |
| Correspondent | Fred Ma Repro-Med Systems, Inc., DBA RMS Medical Products 24 Carpenter Road Chester, NY 10918 |
| 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 | 2016-09-19 |
| Decision Date | 2017-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00659443000001 | K162613 | 000 |