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510(k) K871139

M-10 VENTILATION MONITOR by Bio-Med Devices, Inc. — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1987
Date Received
March 23, 1987
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 Bio-Med Devices, Inc.

  • K213948 — OxyMinder (March 17, 2022)
  • K173973 — TV-100 (July 20, 2018)
  • K942938 — CROSSVENT-4 VENTILATOR (September 19, 1995)
  • K896380 — IC-2A MRI ADULT/PEDIATRIC VENTILATOR (February 12, 1990)
  • K896381 — MVP-10 MRI INFANT VENTILATOR (February 12, 1990)
  • K873614 — CBG CUFF MANOMETER (January 22, 1988)
  • K871337 — M-2 OXYGEN/TEMPERATURE MONITOR (June 5, 1987)
  • K871336 — M-1 PRESSURE MONITOR (June 5, 1987)
  • K830230 — PROGRAMMABLE VENTILATOR (February 9, 1983)
  • K823861 — ET-3 EMERGENCY TRANSPORT VENTILATOR (February 7, 1983)

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)