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510(k) K200401

Device
Apogee
Applicant
Incoba Ltd D/B/A Dynaris
510(k) number
K200401
Product code
NFB
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-14
Date received
2020-02-18
Regulation
868.5905
Classification name
Conserver, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lon Aylsworth
Address
Spirit 40 Park Dr. Suite 260 Chesterfield MO US 63005 63005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NFB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory2025-07-24
K220591ProximaDynasthetics, LLC2022-12-15
K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLC2022-10-17
K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs2016-03-11
K131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC2013-10-11
K113111CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTIONInovo, Inc.2011-12-08
K103392CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVERInovo, Inc.2010-12-17
K090421MODEL 350G GAS CONSERVERInspired Technologies, Inc.2009-05-29
K070740CHAD THERAPEUTICS BONSAI MODEL 800Chad Therapeutics, Inc.2007-05-07
K060751INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATORInovo, Inc.2006-07-18
K060382FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1Ameriflo Corp.2006-04-19
K052563INOGEN SATELLITE CONSERVER, MODEL SC-100Medical Electronic Devices, Inc.2005-10-24
K051988OXY-SERVE II OXYGEN CONSERVING REGULATORSuperior Products, Inc.2005-09-21
K051540INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATORInovo, Inc.2005-09-21
K051007ACCU02 SYSTEMMiti Corp.2005-06-16