K Number
Device Name
Decision Date
Decision
Applicant
Proxima
Dec 15, 2022
Substantially Equivalent
Dynasthetics LLC
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Oct 17, 2022
Substantially Equivalent
Effortless Oxygen. LLC
Apogee
Nov 14, 2020
Substantially Equivalent
Incoba Ltd. d/b/a Dynaris
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
Mar 11, 2016
Substantially Equivalent
Salter Labs
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
Oct 11, 2013
Substantially Equivalent
MEDICAL PRODUCTS, LLC
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
Dec 08, 2011
Substantially Equivalent
INOVO, INC.
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
Dec 17, 2010
Substantially Equivalent
INOVO, INC.
MODEL 350G GAS CONSERVER
May 29, 2009
Substantially Equivalent
INSPIRED TECHNOLOGIES, INC.
CHAD THERAPEUTICS BONSAI MODEL 800
May 07, 2007
Substantially Equivalent
CHAD THERAPEUTICS, INC.
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
Jul 18, 2006
Substantially Equivalent
INOVO, INC.
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
Apr 19, 2006
Substantially Equivalent
AMERIFLO CORP.
INOGEN SATELLITE CONSERVER, MODEL SC-100
Oct 24, 2005
Substantially Equivalent
MEDICAL ELECTRONIC DEVICES, INC.
OXY-SERVE II OXYGEN CONSERVING REGULATOR
Sep 21, 2005
Substantially Equivalent
SUPERIOR PRODUCTS, INC.
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
Sep 21, 2005
Substantially Equivalent
INOVO, INC.
ACCU02 SYSTEM
Jun 16, 2005
Substantially Equivalent
MITI CORP.
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
Sep 20, 2004
Substantially Equivalent
CHAD THERAPEUTICS, INC.
FLO-RITE
Aug 12, 2004
Substantially Equivalent
AMERIFLO CORP.
EOCD
Jul 21, 2004
Substantially Equivalent
RESPIRONICS, INC.
INOGEN SATELLITE CONSERVER
May 13, 2004
Substantially Equivalent
MEDICAL ELECTRONIC DEVICES, INC.
CHAD THERAPEUTICS SAGE
May 11, 2004
Substantially Equivalent
CHAD THERAPEUTICS, INC.
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
Oct 01, 2003
Substantially Equivalent
ESSEX MEDICAL SYSTEMS PLUS
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
Sep 15, 2003
Substantially Equivalent
INOVO, INC.
EASY PULSE II OXYGEN CONSERVER
Aug 25, 2003
Substantially Equivalent
PRECISION MEDICAL, INC.
AIRLIFE DEMAND NASAL CANNULA
May 02, 2003
Substantially Equivalent
ALLEGIANCE HEALTHCARE CORP.
6203
Feb 13, 2003
Substantially Equivalent
CONTEMPORARY PRODUCTS, INC.
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
Oct 25, 2002
Substantially Equivalent
MEDICAL ELECTRONIC DEVICES, INC.
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
Jul 05, 2002
Substantially Equivalent
CHAD THERAPEUTICS, INC.
DEVILBISS PD1000
Jun 19, 2002
Substantially Equivalent
SUNRISE MEDICAL HHG, INC.
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
May 16, 2001
Substantially Equivalent
WESTERN ENT.
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
Mar 23, 2001
Substantially Equivalent
CHAD THERAPEUTICS, INC.
PM 1800 CONSERVING DEVICE
Mar 20, 2001
Substantially Equivalent
PRECISION MEDICAL, INC.
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
Dec 06, 2000
Substantially Equivalent
CHAD THERAPEUTICS, INC.
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
Oct 24, 2000
Substantially Equivalent
INVACARE CORP.
IMPULSE SELECT
Aug 31, 2000
Substantially Equivalent
AIRSEP CORP.
OCD2001
Jun 20, 2000
Substantially Equivalent
CONTEMPORARY PRODUCTS, INC.
CHAD THERAPEUTICS OXYMATIC MODEL 401
Jun 16, 2000
Substantially Equivalent
CHAD THERAPEUTICS, INC.
O2N DEMAND-II, VICTOR MODEL OCPR-II
Sep 03, 1999
Substantially Equivalent
THERMADYNE HOLINGS CORP.
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
Jul 12, 1999
Substantially Equivalent
TRANSTRACHEAL SYSTEMS
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
May 07, 1999
Substantially Equivalent
SALTER LABS
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
Dec 15, 1998
Substantially Equivalent
MEDICAL ELECTRONIC DEVICES, INC.
PULSED OXYGEN CONSERVING DEVICE, POCD
Dec 08, 1998
Substantially Equivalent
MEDICAL ELECTRONIC DEVICES, INC.
SANPO I
Sep 26, 1997
Substantially Equivalent
KOIKE MEDICAL CO.
FLOTEC OXYSAVRR (S)
Jul 10, 1997
Substantially Equivalent
FLOTEC, INC.
VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
Nov 07, 1996
Substantially Equivalent
THERMADYNE HOLINGS CORP.
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
Oct 23, 1996
Substantially Equivalent
TRANSTRACHEAL SYSTEMS
PULSE DOSE SERIES
Oct 21, 1996
Substantially Equivalent
DEVILBISS HEALTH CARE, INC.
AIRSEP IMPULSE
Oct 10, 1996
Substantially Equivalent
AIRSEP CORP.
OXYPULSE EOC I, EOC II & EOC R
Feb 16, 1996
Substantially Equivalent
EAGLE MEDICAL EQUIPMENT CO.
MODEL IPD OXYGEN CONSERVING DEVICE
Nov 22, 1995
Substantially Equivalent
INVACARE CORP.
MEDISONIC OXYGEN FLOW CONTROLLER
Jan 27, 1993
Substantially Equivalent
MEDISONIC U.S.A., INC.