BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MASIMO CORPORATION

    Reg #: 3011353843 · FEI: 3011353843 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    113
    Establishment Types
    1
    Classifications
    40

    Registration Details

    Registration Name
    MASIMO CORPORATION
    Registration Number
    3011353843
    FEI Number
    3011353843
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    52 Discovery
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173976

    Owner / Operator

    Firm Name
    MASIMO CORPORATION
    Operator Number
    9031881
    Address
    52 Discovery, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Oximeter DQA
    Monitor, Breathing Frequency BZQ
    Monitor, Bed Patient KMI
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Computer, Diagnostic, Programmable DQK
    Oximeter, Ear DPZ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Blood Pressure Cuff DXQ
    Alarm, Blood-Pressure DSJ
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Connector, Airway (Extension) BZA
    Full-Montage Standard Electroencephalograph GWQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Hyperoxia Monitoring Device Adjunct To Pulse Oximetry QWE
    Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use QYU
    Burst Suppression Detection Software For Electroencephalograph ORT
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY
    Index-Generating Electroencephalograph Software OLW
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Oximeter, Tissue Saturation MUD
    Oximeter, Infrared, Sporting, Aviation OCH
    Cannula, Nasal, Oxygen CAT
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Oximeter, Reprocessed NLF
    Medical Device Data System OUG
    System, Network And Communication, Physiological Monitors MSX

    Proprietary Names

    RAS-45 Neo M-LNCS Blue LNCS Blue Root Centroid Red MNC Cable NC Adapter Cable MNC Cable RD SET Neo MAC Adapter Cable AC-1 Adapter Cable rainbow DCI-mini Rad-67 Pronto Radius VSM and Accessories Radius VSM RAS-45 Rad-97 Radical Docking Station Radical-7 RAS-125 RAS-125c RAS-45 LiDCOunity v2 Hemodynamic Monitor LiDCO Module Radius T RD rainbow Lite SET-1 RD rainbow 4 Lambda RD rainbow SET-2 Stork Hub Stork Vitals Stork Vitals+ Stork Sensor Radius-7 SedLine Sensors SedLine Module RD SedLine Sensors uSpO2 Cables O3 Sensor O3 Regional Oximetry Rad-G Sensor Rad-G YI Rad-G iSpO2 MightySat NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare SpO2.com Sensors Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC RD SET DBI DBI-dc LNCS DBI Red DBI M-LNCS DBI RD SET TF-I M-LNCS TF-I LNCS TF-I rainbow SpCO Disposable Sensors LNCS-II rainbow 8 Lambda RD rainbow 8 Lambda EMMA Airway Adapter Radius PCG EMMA LNCS Sterile Sensors MightySat Rx rainbow SpHb Disposable Sensors MLNCS E1 LNCS E1 IRMA Airway Adapter IRMA AX+ IRMA CO2 RD SET TFA-1 M-LNCS TFA-1 LNCS TFA-1 M-LNCS Red TFA-1 RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors Radius PPG and Accessories Masimo SafetyNet LNCS YI M-LNCS YI RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors M-LNCS Sterile Sensors M-LNCS Reprocessed Sterile Sensors IntelliVue Module Rainbow ReSposable Sensors Rainbow ReSposable U Sensors CareScape SpO2 - Masimo rainbow SET IntelliVue Module LNCS Reprocessed Sterile Sensors Rad-5v Rad-5 Masimo SET Rad 57 cm Pulse CO-Oximeter Masimo SET Rad 57 m Pulse CO-Oximeter Masimo SET Red reusable sensors Patient SafetyNet

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility