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510(k) K921565

Device
Cardiopulmonary Metabolic Measuement Cart
Applicant
QUITON INSTRUMENT CO.
510(k) number
K921565
Product code
BZL
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-11
Date received
1992-04-01
Regulation
868.1730
Classification name
Computer, Oxygen-Uptake
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GREG W SHIPP
Address
2121 Terry Ave. Seattle WA US 98121 98121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BZL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200076Breezing MedTf Health Co.2020-09-25
K190561NICU V'02Cosmed Nordic Aps2020-09-04
K110810ANASCIENT BREATH MONITORInvoy Technologies, LLC2011-06-21
K093080METAPHOR METABOLIC MONITORTreymed, Inc.2010-01-22
K071533FITMATE SERIESCosmed Srl2007-09-28
K070858EXPRESS SERIESMedical Graphics Corp.2007-04-16
K061731MEDGRAPHICS ULTIMA SYSTEMMedical Graphics Corp.2006-09-06
K021490REEVUE INDIRECT CALORIMETER, MODEL#8100Korr Medical Technologies, Inc.2003-01-02
K021605MEDGEMHealthetech, Inc.2002-06-14
K010577BODYGEM, MODEL HB211Healthetech, Inc.2002-01-10
K954731OXYLOG 2P.K. Morgan , Ltd.1997-01-06
K9249787250 METABOLIC MONITORPuritan Bennett Corp.1994-09-22
K931422DELTATRAC(TM) II METABOLIC MONITORDatex Division Instrumentarium Corp.1993-11-24
K922660PHYSIO-DYNE EASI - LABPhysio-Dyne1993-04-08
K912906MEDGRAPHICS PF/DXMedical Graphics Corp.1992-02-04