510(k) K974332

VARIABLE PRESSURE SYRINGE PUMP by Alaris Medical Systems, Inc. — Product Code FRN

K974332 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "VARIABLE PRESSURE SYRINGE PUMP". The FDA issued a decision of Substantially Equivalent on Dec 29, 1998. 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
Dec 29, 1998
Date Received
Nov 18, 1997
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