FDA 510(k) Applications Submitted by MASIMO CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K111403 05/19/2011 MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION
K111621 06/10/2011 MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS MASIMO CORPORATION
K111888 07/01/2011 MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS MASIMO CORPORATION
K121912 07/02/2012 E1 EAR SENSORS MASIMO CORPORATION
K121914 07/02/2012 MASIMO SET USPO2 PULSE OXIMETRY CABLE MASIMO CORPORATION
K113596 12/05/2011 MASIMO SET REUSABLE OXIMETRY SENSORS MASIMO CORPORATION
K050068 01/12/2005 LNOPV AD-L AND PD-L OXIMETRY SENSORS MASIMO CORPORATION
K060143 01/19/2006 LNCS AND SPO2.COM SENSORS MASIMO CORPORATION
K050252 02/03/2005 AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS MASIMO CORPORATION
K071024 04/11/2007 MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION
K061204 05/01/2006 MASIMO SET RADICAL 7 PULSE CO-OXIMETER MASIMO CORPORATION
K051212 05/11/2005 MODIFICATION TO LNCS OXIMETRY SENSORS MASIMO CORPORATION
K051439 06/02/2005 LNOP BLUE OXIMETRY SENSOR MASIMO CORPORATION
K042346 08/30/2004 LNCS OXIMETRY SENSORS MASIMO CORPORATION
K042536 09/20/2004 MASIMO SET RAD 57 PULSE CO-OXIMETER MASIMO CORPORATION
K063140 10/16/2006 RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION
K053477 12/14/2005 MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS MASIMO CORPORATION
K053269 11/23/2005 MASIMO SET RAD-8 PULSE OXIMETER MASIMO CORPORATION
K173976 12/29/2017 Masimo Acoustic Respiration Sensors, infant and neonate Masimo Corporation
K181956 07/23/2018 Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation
K170168 01/19/2017 Masimo Rad-97 and Accessories MASIMO CORPORATION
K090165 01/22/2009 RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 MASIMO CORPORATION
K140188 01/24/2014 MASIMO ROOT MONITORING SYSTEM MASIMO CORPORATION
K150314 02/09/2015 Masimo MightySat Rx Fingertip Pulse Oximeter MASIMO CORPORATION
K100403 02/16/2010 MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 MASIMO CORPORATION
K100428 02/16/2010 MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER MASIMO CORPORATION
K160526 02/25/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION
K100617 03/04/2010 MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D MASIMO CORPORATION
K090662 03/12/2009 MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP MASIMO CORPORATION
K160940 04/04/2016 Masimo Disposable Transflectance Forehead Sensor Masimo Corporation
K071047 04/13/2007 MASIMO PATIENT SAFETY NET MASIMO CORPORATION
K091057 04/13/2009 MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION
K101031 04/13/2010 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 MASIMO CORPORATION
K171121 04/17/2017 Masimo Root Monitoring System and Accessories Masimo Corporation
K091241 04/27/2009 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER MASIMO CORPORATION
K081659 06/12/2008 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L MASIMO CORPORATION
K151644 06/18/2015 Masimo Root Vital Signs Monitoring System and Accessories MASIMO CORPORATION
K101896 07/07/2010 MASIMO LNCS/M-LNCS OXIMETRY SENSORS MASIMO CORPORATION
K082052 07/21/2008 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK MASIMO CORPORATION
K142394 08/27/2014 Masimo Root Monitoring System and Accesories MASIMO CORPORATION
K092838 09/15/2009 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 MASIMO CORPORATION
K162603 09/19/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION
K162675 09/26/2016 Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter MASIMO CORPORATION
K073024 10/26/2007 MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION
K153225 11/06/2015 Masimo Root Monitoring System and Accessories Masimo Corporation
K083622 12/08/2008 LNCS OXIMETRY SENSORS MASIMO CORPORATION
K083719 12/15/2008 LNCS OXIMETRY SENSORS MASIMO CORPORATION
K094046 12/31/2009 LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS MASIMO CORPORATION
K080238 01/31/2008 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER MASIMO CORPORATION
K172890 09/22/2017 SedLine Sedation Monitor Masimo Corporation
K120657 03/05/2012 MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS MASIMO CORPORATION
K120984 04/02/2012 MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR MASIMO CORPORATION
K110028 01/05/2011 MASIMO RADICAL Y PULSE CO-OXIMETER MASIMO CORPORATION
K110723 03/16/2011 M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS MASIMO CORPORATION
K180046 01/08/2018 Masimo Rad-97 and Accessories Masimo Corporation
K182429 09/06/2018 Masimo O3 Regional Oximeter System Masimo Corporation
K182887 10/15/2018 Masimo Rad-67 Pulse CO-Oximeter and Accessories Masimo Corporation
K183697 12/31/2018 Masimo Rad-97 and Accessories Masimo Corporation


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