The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Hospira Phoenix Infusion System With Hospira Mednet Software.
Device ID | K041550 |
510k Number | K041550 |
Device Name: | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
Classification | Pump, Infusion |
Applicant | ABBOTT LABORATORIES D-389, BLDG. J45-2 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6157 |
Contact | Patricia Melerski |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-06-09 |
Decision Date | 2004-06-30 |
Summary: | summary |