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510(k) K852433

INFUSAFE 205 CATOLOG NO. 205.000 by Medix Medical Electronics (U.S.A.), Inc. — Product Code FLN

K852433 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "INFUSAFE 205 CATOLOG NO. 205.000". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
June 10, 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 Medix Medical Electronics (U.S.A.), Inc.

  • K861040 — ENTERNAL INFUSER MULTIPUMP 203 (June 23, 1986)
  • K861001 — PARENTERAL INFUSER MEDIPUMP 204 (June 12, 1986)
  • K853393 — INSULIN PUMP INSUMAT 229 (November 18, 1985)
  • K813562 — SYRINGE DRIVER 209 (February 1, 1982)
  • K812041 — VENTI-MONITOR MODEL 101 (September 25, 1981)
  • K812039 — SPIROMETER 210/211 (September 25, 1981)
  • K812045 — INFANT APNEA MONITOR MODEL 100 (September 24, 1981)
  • K812040 — OXYGEN MONITOR 140/141 (September 21, 1981)
  • K812046 — TIDAL VOLUME MONITOR 150 (August 7, 1981)
  • K812044 — RESPIRATION RATE MONITOR 120/121 (August 4, 1981)

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