510(k) K965230

ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP by Abbott Mfg., Inc. — Product Code FRN

K965230 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on July 3, 1997. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1997
Date Received
December 31, 1996
Clearance Type
Traditional
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