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510(k) K812046

TIDAL VOLUME MONITOR 150 by Medix Medical Electronics (U.S.A.), Inc. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
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)
  • K852433 — INFUSAFE 205 CATOLOG NO. 205.000 (June 27, 1985)
  • K813562 — SYRINGE DRIVER 209 (February 1, 1982)
  • K812039 — SPIROMETER 210/211 (September 25, 1981)
  • K812041 — VENTI-MONITOR MODEL 101 (September 25, 1981)
  • K812045 — INFANT APNEA MONITOR MODEL 100 (September 24, 1981)
  • K812040 — OXYGEN MONITOR 140/141 (September 21, 1981)
  • K812044 — RESPIRATION RATE MONITOR 120/121 (August 4, 1981)

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