PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE


Device Classification Name

pump, infusion

510(k) Number K081412
Device Name PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
Applicant
HOSPIRA, INC.
275 north field dr.
d-389, bldg., h2
lake forest, 
IL 
60045

Applicant Contact daniela weksler
Regulation Number 880.5725
Classification Product Code
FRN  
Date Received 05/20/2008
Decision Date 12/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls