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510(k) K133870

FLUID LEVEL MONITOR by Coleman Laboratories — Product Code FLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2014
Date Received
December 20, 2013
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 by Coleman Laboratories

  • K802256 — TRIGLYCERIDES DETERMINATION (October 23, 1980)

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  • 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)