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510(k) K080704

LOW FLUID ALARM by Em-Tec GmbH — Product Code FLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2008
Date Received
March 12, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

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 Em-Tec GmbH

  • K111730 — SONOTT FLOWLAB(R) (January 6, 2012)
  • K040909 — SONO TT ULTRASONIC FLOWCOMPUTER (April 20, 2004)

Other clearances for product code FLN

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  • K150687 — DripAssist (October 13, 2015)
  • K133870 — FLUID LEVEL MONITOR (April 24, 2014)
  • 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)
  • K972084 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (July 3, 1997)