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510(k) K760931

I.V. DRIP MONITOR ALARM DEVICE, MONIFLO by Diemolding Corp. — Product Code FLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1977
Date Received
October 29, 1976
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 Diemolding Corp.

  • K962749 — THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PO (October 10, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K902713 — ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS (July 25, 1990)
  • K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (July 18, 1990)
  • K900754 — RESPIREX 2 (March 15, 1990)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K781759 — RESCAL (November 27, 1978)
  • K780750 — O2 CONNECTOR (July 27, 1978)
  • K770369 — VACON TM (March 1, 1977)
  • K760636 — ORTHOMIX (October 5, 1976)

Other clearances for product code FLN

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  • 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)