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510(k) K853393

INSULIN PUMP INSUMAT 229 by Medix Medical Electronics (U.S.A.), Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
August 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
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)
  • K852433 — INFUSAFE 205 CATOLOG NO. 205.000 (June 27, 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)

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