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510(k) K812041

VENTI-MONITOR MODEL 101 by Medix Medical Electronics (U.S.A.), Inc. — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1981
Date Received
July 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
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)
  • 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 CAP

  • K201666 — SINGLE USE MANOMETER (November 13, 2020)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K172284 — NAPA LP-15 Airway Pressure Monitor (February 9, 2018)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K122077 — MANOMETER (January 10, 2013)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)