FDA.reportPublic FDA data

510(k) K050153

Device
SPIRIT, MODEL HAS
Applicant
Caire, Inc.
510(k) number
K050153
Product code
BYJ
Decision
Substantially Equivalent (SESE)
Decision date
2005-04-15
Date received
2005-01-24
Regulation
868.5655
Classification name
Unit, Liquid-Oxygen, Portable
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAN CHLAN
Address
1800 Sandy Plains Industrial Pkwy., Suite 316 Marietta GA US 30066 30066

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of M2013-07-19
K113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.2012-06-29
K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.2011-04-21
K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.2010-08-20
K081779GOLOX-93Respironics, Inc.2008-09-19
K080023MODIFICATION TO: SPIRITCaire, Inc.2008-06-16
K072723RESPIRONICS GOLOXRespironics, Inc.2008-03-20
K072011COPD LIQUID OXYGEN PORTABLE, MODEL 300PCopd Partners, Inc.2007-10-18
K071581BACKPACK MEDICAL OXYGEN SYSTEMEssex Cryogenics of Missouri, Inc.2007-07-11
K050414PLIXRespironics, Inc.2005-04-11
K041122PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.2004-10-04
K032143LIQUID OXYGEN SYSTEMMicro Technology Services, Inc.2004-03-30
K033000NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEMEssex Cryogenics of Missouri, Inc.2004-03-22
K013251SPIRIT 300Caire, Inc.2001-12-18
K993220PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEMPuritan Bennett Corp.1999-10-22