The following data is part of a premarket notification filed by Hospira, Inc with the FDA for Plum 360(tm) Infusion System With Mednet/ Smart Card Plug And Play Module.
| Device ID | K161469 |
| 510k Number | K161469 |
| Device Name: | Plum 360(TM) Infusion System With MedNet/ Smart Card Plug And Play Module |
| Classification | Pump, Infusion |
| Applicant | Hospira, Inc 275 North Field Drive Lake Forest, IL 60045 |
| Contact | Keith Dunn |
| Correspondent | Keith Dunn Hospira, Inc 275 North Field Drive Lake Forest, IL 60045 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | PHC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-27 |
| Decision Date | 2017-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3353001004141 | K161469 | 000 |
| M3353001004131 | K161469 | 000 |
| M3353001004101 | K161469 | 000 |
| M3353001004091 | K161469 | 000 |