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510(k) K812038

OXYGEN CONTROLLER MODEL 145 by Medix Medical Electronics (U.S.A.), Inc.

K812038 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "OXYGEN CONTROLLER MODEL 145". The FDA issued a decision of Substantially Equivalent on July 21, 1981. 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
July 21, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)

FDA data resources