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510(k) K221014

Device
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Applicant
Effortless Oxygen, LLC
510(k) number
K221014
Product code
NFB
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-17
Date received
2022-04-05
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
Samir Ahmad
Address
251 E Sierra Dr. Phoenix AZ US 85012 85012

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
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K200401ApogeeIncoba Ltd D/B/A Dynaris2020-11-14
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