FDA.report

NONIN MEDICAL, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
21836462183646NONIN MEDICAL, INC.1Y2026-01-0113700 1ST AVE, NORTH Plymouth MN US 55441

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
790441343926486K982969NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847CCK1999-08-12
790441512425742K942248MINIATURIZED FINGER CLIP PULSE OXIMETERDQA1994-12-08
790441556840677K893221MODEL 8500 HAND HELD PULSE OXIMETERDQA1990-02-28
790442014697952K192900H500 Multi-Sensing Oximetry SystemDQA2020-06-29
790441110524791K191403Pulse OximeterDQA2019-12-20
790441200529221K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InterfaceMUD2019-05-02
790441694481502K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter SensoDQA2016-08-05
790441852499318K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)MUD2015-08-27
790441732684924K140785PULSE OXIMETERDQA2014-07-07
790441315510451K132402SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEMDQA2014-02-21
790441726247631K131021PULSE OXIMETERDQA2013-09-11
790441913714117K112843PULSE OXIMETERDQA2012-04-19
790441128984122K102350PULSE OXIMETERDQA2010-12-22
790441919668424K093853SINGLE-PATIENT USE DISPOSABLE SENSOR SERIESDQA2010-06-04
790441030444720K093306SINGLE-PATIENT USE DISPOSABLE SENSORDQA2010-03-04
790441529283767K092678EVISION DATA MANAGEMENT SOFTWAREDQA2009-10-01
790441507158599K092101REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIESDQA2009-10-21
790441588224382K090807REGIONAL OXIMETER SYSTEM, MODEL 7600MUD2009-06-30
790441000559893K081285FINGER PULSE OXIMETER, MODEL 9560DQA2008-06-05
790441183261352K080255NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETERDQA2008-05-23
790441221713413K071415DIGITAL PULSE OXIMETER, MODEL 7500FODQA2007-08-08
790441784669736K071285DIGITAL PULSE OXIMETER, MODEL 7500DQA2007-07-12
790441824957426K063752LIFESENSE, MODEL LS1-9RDQA2007-05-04
790441707097404K051107ONYX II FINGER PULSE OXIMETER, MODEL 9550DQA2005-06-01
790441840662227K050056MODEL 2500A PALMSAT PULSE OXIMETERDQA2005-06-21
790441340752584K0433594100 PATIENT OXIMETER MODULEDQA2005-01-07
790441225363281K041156AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001DQA2004-06-09
790441967044033K040589MODIFICATION TO AVANT 9600 PULSE OXIMETERDQA2004-06-03
790441048190560K023044MODEL 9600, AVANT PULSE OXIMETERDQA2003-07-23
790441752135077K013319NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITORDQA2002-01-03
790441488547973K002690MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500DQA2000-10-11
790441392500699
790441392667356

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DQA272020-06-29
MUD32019-05-02
CCK11999-08-12

PMA

PMN

Applications

GUDID