510(k) K973025

FLUID CENTURION (4-100-00) by Northgate Technologies, Inc. — Product Code FLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1997
Date Received
August 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Device Class
Class II
Regulation Number
880.2420
Review Panel
HO
Submission Type