510(k) K141102

HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE by Hospira, Inc. — Product Code FRN

K141102 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE". The FDA issued a decision of Substantially Equivalent on July 8, 2014. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Hospira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2014
Date Received
April 29, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type