BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MASIMO CORPORATION

    Reg #: 3009831876 · FEI: 3009831876 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    32

    Registration Details

    Registration Name
    MASIMO CORPORATION
    Registration Number
    3009831876
    FEI Number
    3009831876
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9600 Jeronimo
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121914

    Owner / Operator

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

    Products

    Device Name Product Code
    Oximeter DQA
    Electrode, Cutaneous GXY
    Cannula, Nasal, Oxygen CAT
    Full-Montage Standard Electroencephalograph GWQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Monitor, Breathing Frequency BZQ
    Burst Suppression Detection Software For Electroencephalograph ORT
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Oximeter, Ear DPZ
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Continuous Measurement Thermometer FLL
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Reduced- Montage Standard Electroencephalograph OMC
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    System, Network And Communication, Physiological Monitors MSX
    Connector, Airway (Extension) BZA
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Computer, Diagnostic, Programmable DQK
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Blood Pressure Cuff DXQ
    Alarm, Blood-Pressure DSJ
    Monitor, Bed Patient KMI
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph DPS
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    uSpO2 Cables NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare Rad-G Sensor Rad-G YI Rad-G Patient SafetyNet RAS-125 RAS-125c RAS-45 Masimo SET Rad 57 cm Pulse CO-Oximeter Masimo SET Rad 57 m Pulse CO-Oximeter Masimo SET Red reusable sensors Pronto Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC RAS-45 Neo LNCS YI M-LNCS YI IntelliVue Module Radius VSM and Accessories Radius VSM RAS-45 CareScape SpO2 - Masimo rainbow SET IntelliVue Module RD SET TF-I M-LNCS TF-I LNCS TF-I

    Establishment Types

    Repack or Relabel Medical Device