Atlas FDA

BZL

33 FDA 510(k) clearances · Product code

107 daysmedian time to decision
448 days90th percentile
33clearances measured

FDA profile

Official device name
Computer, Oxygen-Uptake
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1730
Medical specialty
Anesthesiology
Flags
Third-party review eligible
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RecordFirmDate
Breezing Med (K200076)Tf Health Co.2020-09-25
NICU V'02 (K190561)Cosmed Nordic Aps2020-09-04
ANASCIENT BREATH MONITOR (K110810)Invoy Technologies, LLC2011-06-21
METAPHOR METABOLIC MONITOR (K093080)Treymed, Inc.2010-01-22
FITMATE SERIES (K071533)Cosmed Srl2007-09-28
EXPRESS SERIES (K070858)Medical Graphics Corp.2007-04-16
MEDGRAPHICS ULTIMA SYSTEM (K061731)Medical Graphics Corp.2006-09-06
REEVUE INDIRECT CALORIMETER, MODEL#8100 (K021490)Korr Medical Technologies, Inc.2003-01-02
MEDGEM (K021605)Healthetech, Inc.2002-06-14
BODYGEM, MODEL HB211 (K010577)Healthetech, Inc.2002-01-10
OXYLOG 2 (K954731)P.K. Morgan , Ltd.1997-01-06
7250 METABOLIC MONITOR (K924978)Puritan Bennett Corp.1994-09-22
CARDIOPULMONARY METABOLIC MEASUEMENT CART (K921565)Quiton Instrument Co.1994-08-11
DELTATRAC(TM) II METABOLIC MONITOR (K931422)Datex Division Instrumentarium Corp.1993-11-24
PHYSIO-DYNE EASI - LAB (K922660)Physio-Dyne1993-04-08
MEDGRAPHICS PF/DX (K912906)Medical Graphics Corp.1992-02-04
OXYMAX (K895791)Columbus Instruments Intl. Corp.1990-03-28
ICOR CMU Q PLUS (K895935)Icor AB1990-01-04
VVR/Q CALORIMETER (K895586)Vita-Stat1989-09-22
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM (K874663)Ametek/Thermox Instruments Division1988-05-31
DELTATRAC(TM) METABOLIC MONITOR (K864603)Datex Division Instrumentarium Corp.1987-03-17
VISTA INTERFACE SYSTEM (K864852)Vacumetrics, Inc.1987-03-04
ICOR CALARIC MEASUREMENT UNIT (CMU) (K854927)Icor AB1986-03-27
ERGO-PNEUMOTEST (K853434)Erich Jaeger, Inc.1986-02-05
RESPIRATORY ASSESSMENT SYSTEM (K833714)Thoratec Laboratories Corp.1983-12-29
METABOLIC EXERCISE TESTING SYSTEM (K831780)Warren E. Collins, Inc.1983-09-12
CPM METABOLIC MONITOR (K823695)Medicor USA , Ltd.1983-01-14
METABOLIC MEASUREMENT CART (K822710)Beckman Instruments, Inc.1982-10-13
ENGSTROM METABOLIC COMPUTER (K821344)Lkb Instruments, Inc.1982-05-28
BECKMAN MMC II METABOLIC MEAS. CART (K820905)Beckman Instruments, Inc.1982-05-14
MGC/LITTON 2300 (K820475)Medical Graphics Corp.1982-03-23
AB O2 CONSUMPTION CALCULATOR 980 (K802417)Siemens Elema AB1980-10-23
MRM-2 OXYGEN CONSUMPTION MONITOR (K801852)Waters Assoc., Inc.1980-08-20

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