The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Plum A+ Hyperbaric Infusion System With Hospira Mednet Software.
| Device ID | K081412 |
| 510k Number | K081412 |
| Device Name: | PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
| Classification | Pump, Infusion |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. D-389, BLDG., H2 Lake Forest, IL 60045 |
| Contact | Daniela Weksler |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-20 |
| Decision Date | 2008-12-17 |
| Summary: | summary |