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510(k) K910323

BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) by Uab Research Foundation — Product Code FLN

K910323 is an FDA 510(k) premarket notification submitted by Uab Research Foundation for the device "BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)". The FDA issued a decision of Substantially Equivalent on October 3, 1991. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1991
Date Received
January 24, 1991
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

Other clearances for product code FLN

  • K172242 — DripAssist Plus (May 25, 2018)
  • K150687 — DripAssist (October 13, 2015)
  • K133870 — FLUID LEVEL MONITOR (April 24, 2014)
  • K080704 — LOW FLUID ALARM (April 17, 2008)
  • K050783 — ISSYS DRUG FLOW MONITOR (February 22, 2006)
  • K060123 — LEVELERT II FLUID LEVEL SENSOR (February 14, 2006)
  • K030136 — DRIP ALERT (April 7, 2003)
  • K022248 — STRYKER L3 HYDROLERT (August 6, 2002)
  • K013121 — MT ALERT INFUSION MONITOR (October 15, 2001)
  • K973025 — FLUID CENTURION (4-100-00) (November 20, 1997)

FDA data resources