510(k) K893487

LIFECARE 75 CONTROLLER by Abbott Laboratories — Product Code LDR

K893487 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "LIFECARE 75 CONTROLLER". The FDA issued a decision of Substantially Equivalent on July 28, 1989. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1989
Date Received
May 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type