510(k) K993524

ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS by Alaris Medical Systems, Inc. — Product Code FRN

K993524 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on August 1, 2000. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2000
Date Received
October 18, 1999
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