The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Plum A+ Infusion System With Hospira Mednet Software , And Plum A+3 Infusion System With Hospira Mednet Software.
| Device ID | K042081 |
| 510k Number | K042081 |
| Device Name: | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
| Classification | Pump, Infusion |
| Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. 2 Lake Forest, IL 60045 -5045 |
| Contact | Tom Kozma |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2004-08-24 |
| Summary: | summary |