Product Code: BZL FDA class 2 21 CFR 868.1730

Computer, Oxygen-Uptake

Anesthesiology

The Computer, Oxygen-Uptake is a device that calculates a patient's oxygen consumption from measurements of respiratory gas composition and flow, used in metabolic studies, exercise testing, and critical care monitoring. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BZL, regulated under 21 CFR 868.1730 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: BZL
Device Class: FDA class 2
Regulation Number: 868.1730
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K200076	Breezing Med	Sep 25, 2020	Substantially Equivalent	Tf Health Co.
K190561	NICU V'02	Sep 04, 2020	Substantially Equivalent	Cosmed Nordic Aps
K110810	ANASCIENT BREATH MONITOR	Jun 21, 2011	Substantially Equivalent	Invoy Technologies, LLC
K093080	METAPHOR METABOLIC MONITOR	Jan 22, 2010	Substantially Equivalent	Treymed, Inc.
K071533	FITMATE SERIES	Sep 28, 2007	Substantially Equivalent	Cosmed Srl
K070858	EXPRESS SERIES	Apr 16, 2007	Substantially Equivalent	Medical Graphics Corp.
K061731	MEDGRAPHICS ULTIMA SYSTEM	Sep 06, 2006	Substantially Equivalent	Medical Graphics Corp.
K021490	REEVUE INDIRECT CALORIMETER, MODEL#8100	Jan 02, 2003	Substantially Equivalent	Korr Medical Technologies, Inc.
K021605	MEDGEM	Jun 14, 2002	Substantially Equivalent	Healthetech, Inc.
K010577	BODYGEM, MODEL HB211	Jan 10, 2002	Substantially Equivalent	Healthetech, Inc.
K954731	OXYLOG 2	Jan 06, 1997	Substantially Equivalent	P.K. Morgan , Ltd.
K924978	7250 METABOLIC MONITOR	Sep 22, 1994	Substantially Equivalent	Puritan Bennett Corp.
K921565	CARDIOPULMONARY METABOLIC MEASUEMENT CART	Aug 11, 1994	Substantially Equivalent	Quiton Instrument Co.
K931422	DELTATRAC(TM) II METABOLIC MONITOR	Nov 24, 1993	Substantially Equivalent	Datex Division Instrumentarium Corp.
K922660	PHYSIO-DYNE EASI - LAB	Apr 08, 1993	Substantially Equivalent	Physio-Dyne
K912906	MEDGRAPHICS PF/DX	Feb 04, 1992	Substantially Equivalent	Medical Graphics Corp.
K895791	OXYMAX	Mar 28, 1990	Substantially Equivalent	Columbus Instruments Intl. Corp.
K895935	ICOR CMU Q PLUS	Jan 04, 1990	Substantially Equivalent	Icor AB
K895586	VVR/Q CALORIMETER	Sep 22, 1989	Substantially Equivalent	Vita-Stat
K874663	MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM	May 31, 1988	Substantially Equivalent	Ametek/Thermox Instruments Division
K864603	DELTATRAC(TM) METABOLIC MONITOR	Mar 17, 1987	Substantially Equivalent	Datex Division Instrumentarium Corp.
K864852	VISTA INTERFACE SYSTEM	Mar 04, 1987	Substantially Equivalent	Vacumetrics, Inc.
K854927	ICOR CALARIC MEASUREMENT UNIT (CMU)	Mar 27, 1986	Substantially Equivalent	Icor AB
K853434	ERGO-PNEUMOTEST	Feb 05, 1986	Substantially Equivalent	Erich Jaeger, Inc.
K833714	RESPIRATORY ASSESSMENT SYSTEM	Dec 29, 1983	Substantially Equivalent	Thoratec Laboratories Corp.
K831780	METABOLIC EXERCISE TESTING SYSTEM	Sep 12, 1983	Substantially Equivalent	Warren E. Collins, Inc.
K823695	CPM METABOLIC MONITOR	Jan 14, 1983	Substantially Equivalent	Medicor USA , Ltd.
K822710	METABOLIC MEASUREMENT CART	Oct 13, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K821344	ENGSTROM METABOLIC COMPUTER	May 28, 1982	Substantially Equivalent	Lkb Instruments, Inc.
K820905	BECKMAN MMC II METABOLIC MEAS. CART	May 14, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K820475	MGC/LITTON 2300	Mar 23, 1982	Substantially Equivalent	Medical Graphics Corp.
K802417	AB O2 CONSUMPTION CALCULATOR 980	Oct 23, 1980	Substantially Equivalent	Siemens Elema AB
K801852	MRM-2 OXYGEN CONSUMPTION MONITOR	Aug 20, 1980	Substantially Equivalent	Waters Assoc., Inc.