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510(k) K853843

IV MATE by Medtech Intl., Inc. — Product Code FLN

K853843 is an FDA 510(k) premarket notification submitted by Medtech Intl., Inc. for the device "IV MATE". The FDA issued a decision of Substantially Equivalent on January 9, 1986. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Medtech Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1986
Date Received
September 16, 1985
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 Medtech Intl., Inc.

  • K920876 — CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER (December 11, 1992)
  • K791462 — HYPERDERMIC NEEDLE WITH SENSOR #514 (September 24, 1979)
  • K790389 — GAUZE & COTTON SPONGES (March 26, 1979)
  • K790467 — SURGICAL EYE SPONGE (March 26, 1979)
  • K781157 — STIMULATOR, NERVE, TRANSCUTANEOUS (September 20, 1978)

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