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510(k) K213948

OxyMinder by Bio-Med Devices, Inc. — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2022
Date Received
December 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

Other clearances by Bio-Med Devices, Inc.

  • 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)
  • K871336 — M-1 PRESSURE MONITOR (June 5, 1987)
  • K871337 — M-2 OXYGEN/TEMPERATURE MONITOR (June 5, 1987)
  • K871139 — M-10 VENTILATION MONITOR (April 21, 1987)
  • K830230 — PROGRAMMABLE VENTILATOR (February 9, 1983)
  • K823861 — ET-3 EMERGENCY TRANSPORT VENTILATOR (February 7, 1983)

Other clearances for product code CCL

  • K251245 — OxyMinder Pro (10310) (August 11, 2025)
  • K250002 — Smart Check O2 (MA0236) (April 24, 2025)
  • K221734 — Maxtec MaxO2 ME+p (April 1, 2023)
  • K213933 — Percent Oxygen Sensors (August 19, 2022)
  • K173807 — Accu O2 Oxygen Analyzer (May 2, 2018)
  • K153659 — MaxO2ME (June 10, 2016)
  • K123195 — CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (February 28, 2013)
  • K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (January 23, 2013)
  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)
  • K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM (November 25, 2008)