The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Gemstar Sp Infusion System With Gemstar Sp Infusion Suite Software.
| Device ID | K083019 |
| 510k Number | K083019 |
| Device Name: | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE |
| Classification | Pump, Infusion |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. DEPT. 389, BLDG. H2 Lake Forest, IL 60045 |
| Contact | Yuliya Matlin |
| 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 | 2008-10-09 |
| Decision Date | 2008-10-22 |
| Summary: | summary |