The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for Smartdose Iv Prefilled Infusion Container.
| Device ID | K944351 |
| 510k Number | K944351 |
| Device Name: | SMARTDOSE IV PREFILLED INFUSION CONTAINER |
| Classification | Pump, Infusion |
| Applicant | RIVER MEDICAL, INC. 7737 KENAMAR CT. San Diego, CA 92121 |
| Contact | Mark Shannon |
| Correspondent | Mark Shannon RIVER MEDICAL, INC. 7737 KENAMAR CT. San Diego, CA 92121 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-06 |
| Decision Date | 1995-11-15 |