FDA 510(k) Applications for Medical Device Product Code "BYJ"
(Unit, Liquid-Oxygen, Portable)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K080023 |
CAIRE, INC. |
MODIFICATION TO: SPIRIT |
06/16/2008 |
K013251 |
CAIRE, INC. |
SPIRIT 300 |
12/18/2001 |
K050153 |
CAIRE, INC. |
SPIRIT, MODEL HAS |
04/15/2005 |
K072011 |
COPD PARTNERS, INC. |
COPD LIQUID OXYGEN PORTABLE, MODEL 300P |
10/18/2007 |
K071581 |
ESSEX CRYOGENICS OF MISSOURI, INC. |
BACKPACK MEDICAL OXYGEN SYSTEM |
07/11/2007 |
K033000 |
ESSEX CRYOGENICS OF MISSOURI, INC. |
NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM |
03/22/2004 |
K101272 |
ESSEX INDUSTRIES, INC. |
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 |
08/20/2010 |
K113767 |
ESSEX INDUSTRIES, INC. |
MOUNTED MEDICAL OXYGEN SYSTEM |
06/29/2012 |
K130068 |
ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M |
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) |
07/19/2013 |
K971545 |
HEALTHDYNE TECHNOLOGIES, INC. |
PROTEGE LIQUID OXYGEN SYSTEM |
07/25/1997 |
K032143 |
MICRO TECHNOLOGY SERVICES, INC. |
LIQUID OXYGEN SYSTEM |
03/30/2004 |
K041122 |
PRECISION MEDICAL, INC. |
PRECISION LIQUID OXYGEN SYSTEM |
10/04/2004 |
K103324 |
PRECISION MEDICAL, INC. |
PRECISION LIQUID OXYGEN SYSTEM |
04/21/2011 |
K993220 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM |
10/22/1999 |
K081779 |
RESPIRONICS, INC. |
GOLOX-93 |
09/19/2008 |
K050414 |
RESPIRONICS, INC. |
PLIX |
04/11/2005 |
K072723 |
RESPIRONICS, INC. |
RESPIRONICS GOLOX |
03/20/2008 |
K963956 |
SOUTHERN RESEARCH, INC. |
PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT |
12/09/1996 |
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