BYJ — Unit, Liquid-Oxygen, Portable Class II

FDA Device Classification

Classification Details

Product Code
BYJ
Device Class
Class II
Regulation Number
868.5655
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130068essex industries, inc. d/b/a essex cryogenics of mDISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)July 19, 2013
K113767essex industriesMOUNTED MEDICAL OXYGEN SYSTEMJune 29, 2012
K103324precision medicalPRECISION LIQUID OXYGEN SYSTEMApril 21, 2011
K101272essex industriesMASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3August 20, 2010
K081779respironicsGOLOX-93September 19, 2008
K080023caireMODIFICATION TO: SPIRITJune 16, 2008
K072723respironicsRESPIRONICS GOLOXMarch 20, 2008
K072011copd partnersCOPD LIQUID OXYGEN PORTABLE, MODEL 300POctober 18, 2007
K071581essex cryogenics of missouriBACKPACK MEDICAL OXYGEN SYSTEMJuly 11, 2007
K050153caireSPIRIT, MODEL HASApril 15, 2005
K050414respironicsPLIXApril 11, 2005
K041122precision medicalPRECISION LIQUID OXYGEN SYSTEMOctober 4, 2004
K032143micro technology servicesLIQUID OXYGEN SYSTEMMarch 30, 2004
K033000essex cryogenics of missouriNEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEMMarch 22, 2004
K013251caireSPIRIT 300December 18, 2001
K993220puritan bennettPURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEMOctober 22, 1999
K971545healthdyne technologiesPROTEGE LIQUID OXYGEN SYSTEMJuly 25, 1997
K963956southern researchPORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNITDecember 9, 1996
K941819hogan and hartsonLIQUID OXYGEN STORAGE SUBSYSTEMMay 23, 1994
K933930puritan bennettPURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNITMarch 21, 1994