FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K962766 |
AIRSEP CORP. |
AIRSEP IMPULSE |
10/10/1996 |
K001579 |
AIRSEP CORP. |
IMPULSE SELECT |
08/31/2000 |
K023673 |
ALLEGIANCE HEALTHCARE CORP. |
AIRLIFE DEMAND NASAL CANNULA |
05/02/2003 |
K041057 |
AMERIFLO CORP. |
FLO-RITE |
08/12/2004 |
K060382 |
AMERIFLO CORP. |
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 |
04/19/2006 |
K070740 |
CHAD THERAPEUTICS, INC. |
CHAD THERAPEUTICS BONSAI MODEL 800 |
05/07/2007 |
K042142 |
CHAD THERAPEUTICS, INC. |
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S |
09/20/2004 |
K000890 |
CHAD THERAPEUTICS, INC. |
CHAD THERAPEUTICS OXYMATIC MODEL 401 |
06/16/2000 |
K010389 |
CHAD THERAPEUTICS, INC. |
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 |
03/23/2001 |
K020475 |
CHAD THERAPEUTICS, INC. |
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 |
07/05/2002 |
K033364 |
CHAD THERAPEUTICS, INC. |
CHAD THERAPEUTICS SAGE |
05/11/2004 |
K003455 |
CHAD THERAPEUTICS, INC. |
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 |
12/06/2000 |
K022865 |
CONTEMPORARY PRODUCTS, INC. |
6203 |
02/13/2003 |
K992935 |
CONTEMPORARY PRODUCTS, INC. |
OCD2001 |
06/20/2000 |
K961126 |
DEVILBISS HEALTH CARE, INC. |
PULSE DOSE SERIES |
10/21/1996 |
K220591 |
Dynasthetics LLC |
Proxima |
12/15/2022 |
K955129 |
EAGLE MEDICAL EQUIPMENT CO. |
OXYPULSE EOC I, EOC II & EOC R |
02/16/1996 |
K221014 |
Effortless Oxygen. LLC |
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile |
10/17/2022 |
K024023 |
ESSEX MEDICAL SYSTEMS PLUS |
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER |
10/01/2003 |
K970371 |
FLOTEC, INC. |
FLOTEC OXYSAVRR (S) |
07/10/1997 |
K200401 |
Incoba Ltd. d/b/a Dynaris |
Apogee |
11/14/2020 |
K103392 |
INOVO, INC. |
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER |
12/17/2010 |
K113111 |
INOVO, INC. |
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION |
12/08/2011 |
K031983 |
INOVO, INC. |
INOVO, INC, ECONOMIZER CONSERVING REGULATOR |
09/15/2003 |
K060751 |
INOVO, INC. |
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR |
07/18/2006 |
K051540 |
INOVO, INC. |
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR |
09/21/2005 |
K090421 |
INSPIRED TECHNOLOGIES, INC. |
MODEL 350G GAS CONSERVER |
05/29/2009 |
K002284 |
INVACARE CORP. |
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX |
10/24/2000 |
K964541 |
KOIKE MEDICAL CO. |
SANPO I |
09/26/1997 |
K983601 |
MEDICAL ELECTRONIC DEVICES, INC. |
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC |
12/15/1998 |
K033197 |
MEDICAL ELECTRONIC DEVICES, INC. |
INOGEN SATELLITE CONSERVER |
05/13/2004 |
K052563 |
MEDICAL ELECTRONIC DEVICES, INC. |
INOGEN SATELLITE CONSERVER, MODEL SC-100 |
10/24/2005 |
K023420 |
MEDICAL ELECTRONIC DEVICES, INC. |
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB |
10/25/2002 |
K983459 |
MEDICAL ELECTRONIC DEVICES, INC. |
PULSED OXYGEN CONSERVING DEVICE, POCD |
12/08/1998 |
K131023 |
MEDICAL PRODUCTS, LLC |
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN |
10/11/2013 |
K051007 |
MITI CORP. |
ACCU02 SYSTEM |
06/16/2005 |
K032018 |
PRECISION MEDICAL, INC. |
EASY PULSE II OXYGEN CONSERVER |
08/25/2003 |
K001412 |
PRECISION MEDICAL, INC. |
PM 1800 CONSERVING DEVICE |
03/20/2001 |
K041568 |
RESPIRONICS, INC. |
EOCD |
07/21/2004 |
K151506 |
Salter Labs |
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula |
03/11/2016 |
K990678 |
SALTER LABS |
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) |
05/07/1999 |
K020329 |
SUNRISE MEDICAL HHG, INC. |
DEVILBISS PD1000 |
06/19/2002 |
K051988 |
SUPERIOR PRODUCTS, INC. |
OXY-SERVE II OXYGEN CONSERVING REGULATOR |
09/21/2005 |
K992659 |
THERMADYNE HOLINGS CORP. |
O2N DEMAND-II, VICTOR MODEL OCPR-II |
09/03/1999 |
K963247 |
THERMADYNE HOLINGS CORP. |
VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR |
11/07/1996 |
K962944 |
TRANSTRACHEAL SYSTEMS |
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) |
10/23/1996 |
K982943 |
TRANSTRACHEAL SYSTEMS |
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 |
07/12/1999 |
K010747 |
WESTERN ENT. |
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 |
05/16/2001 |