Medical Device Manufacturer · US , Irvine , CA

Masimo Corporation - FDA 510(k) Cleared Devices

84 submissions · 82 cleared · Since 2004
84
Total
82
Cleared
2
Denied
84 devices
26-50 of 84
Cleared Dec 27, 2019
Masimo Rad-97 and Accessories
K191059 · MWI
Anesthesiology · 249d
Cleared Jun 07, 2019
Masimo O3 Regional Oximeter System
K182429 · MUD
Neurology · 274d
Cleared May 15, 2019
Masimo Rad-97 and Accessories
K183697 · MWI
Anesthesiology · 135d
Cleared Mar 22, 2019
Masimo Rad-67 Pulse CO-Oximeter and Accessories
K182887 · DQA
Anesthesiology · 158d
Cleared Jan 23, 2019
Masimo MightySat Rx Fingertip Pulse Oximeter
K181956 · DQA
Anesthesiology · 184d
Cleared Oct 23, 2018
Masimo Rad-97 and Accessories
K180046 · DQA
Anesthesiology · 288d
Cleared Sep 05, 2018
Masimo Acoustic Respiration Sensors, infant and neonate
K173976 · BZQ
Anesthesiology · 250d
Cleared Jan 26, 2018
SedLine Sedation Monitor
K172890 · OLW
Neurology · 126d
Cleared Nov 17, 2017
Masimo Root Monitoring System and Accessories
K171121 · MWI
Cardiovascular · 214d
Cleared Sep 14, 2017
Masimo Rad-97 and Accessories
K170168 · MWI
Cardiovascular · 238d
Cleared May 26, 2017
Masimo O3 Regional Oximeter System
K162603 · MUD
Cardiovascular · 249d
Cleared Dec 28, 2016
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · DQA
Anesthesiology · 93d
Cleared Nov 23, 2016
Masimo Disposable Transflectance Forehead Sensor
K160940 · DQA
Anesthesiology · 233d
Cleared Jun 21, 2016
Masimo Root Monitoring System and Accessories
K153225 · MWI
Cardiovascular · 228d
Cleared Jun 09, 2016
Masimo O3 Regional Oximeter System
K160526 · MUD
Cardiovascular · 105d
Cleared Feb 12, 2016
Masimo Root Vital Signs Monitoring System and Accessories
K151644 · MWI
Cardiovascular · 239d
Cleared Oct 22, 2015
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · DQA
Anesthesiology · 255d
Cleared Nov 25, 2014
Masimo Root Monitoring System and Accesories
K142394 · MWI
Cardiovascular · 90d
Cleared Jun 25, 2014
MASIMO ROOT MONITORING SYSTEM
K140188 · MWI
Cardiovascular · 152d
Cleared Apr 26, 2013
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
K120984 · DQA
Anesthesiology · 389d
Cleared Sep 19, 2012
MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
K120657 · DQA
Anesthesiology · 198d
Cleared Sep 07, 2012
MASIMO SET USPO2 PULSE OXIMETRY CABLE
K121914 · DQA
Anesthesiology · 67d
Cleared Jul 24, 2012
E1 EAR SENSORS
K121912 · DQA
Anesthesiology · 22d
Cleared Feb 24, 2012
MASIMO SET REUSABLE OXIMETRY SENSORS
K113596 · DQA
Anesthesiology · 81d
Cleared Dec 30, 2011
MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
K111403 · DQA
Anesthesiology · 225d

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