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510(k) K050783

ISSYS DRUG FLOW MONITOR by Integrated Sensing Systems, Inc. — Product Code FLN

K050783 is an FDA 510(k) premarket notification submitted by Integrated Sensing Systems, Inc. for the device "ISSYS DRUG FLOW MONITOR". The FDA issued a decision of Substantially Equivalent on February 22, 2006. 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
February 22, 2006
Date Received
March 28, 2005
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)
  • 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)
  • K972084 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (July 3, 1997)

FDA data resources