BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Masimo Corporation

    Reg #: 3019388613 · FEI: 3019388613 · Expires 2026
    View on FDA
    Products
    40
    Proprietary Names
    105
    Establishment Types
    1
    Classifications
    40

    Registration Details

    Registration Name
    Masimo Corporation
    Registration Number
    3019388613
    FEI Number
    3019388613
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15750 Alton Parkway
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181956

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

    Proprietary Names

    MightySat Rx uSpO2 Cables Red MNC Cable NC Adapter Cable MNC Cable IRMA Airway Adapter IRMA AX+ IRMA CO2 rainbow SpHb Disposable Sensors LNCS Sterile Sensors Pronto RD rainbow Lite SET-1 RD rainbow 4 Lambda RD rainbow SET-2 Radius VSM and Accessories Radius VSM RAS-45 RD SET CS Disposable Sensors LNCS Disposable Sensors M-LNCS Disposable Sensors Direct Connect Sensors SatShare Cables Masimo SET Radical Pulse Oximeter with SatShare Masimo SafetyNet RD SET Neo iSpO2 MightySat Rad-G Sensor Rad-G YI Rad-G SedLine Sensors SedLine Module RD SedLine Sensors Rad-97 Radical Docking Station Radical-7 Stork Hub Stork Vitals Stork Vitals+ Stork Sensor Red Reusable Sensors LNCS Reusable Sensors M-LNCS Reusable Sensors NomoLine ISA CO2 NomoLine-O Accessories ISA CO2 Module NomoLine ISA OR+ NomoLine ISA AX+ NomoLine Accessories ISA AX+ Module Root Centroid Masimo W1 IntelliVue Module Rad-57 LNCS-II rainbow DCI 8 Lambda rainbow DCI rainbow DCI SC MAC Adapter Cable AC-1 Adapter Cable Rad-5v Rad-5 Radius-7 RAS-45 Neo CareScape SpO2 - Masimo rainbow SET IntelliVue Module RAS-125 RAS-125c RAS-45 rainbow DCI-mini Rad-67 Rainbow ReSposable Sensors Rainbow ReSposable U Sensors RD SET Multisite Reusable sensors RD Speciality sensors RD SET Reusable sensors RD SET Disposable sensors LNCS Reprocessed Sterile Sensors RD SET TF-I M-LNCS TF-I LNCS TF-I M-LNCS Blue LNCS Blue O3 Sensor O3 Regional Oximetry Radius PPG and Accessories LNCS YI M-LNCS YI Patient SafetyNet MLNCS E1 LNCS E1 RD SET TFA-1 M-LNCS TFA-1 LNCS TFA-1 M-LNCS Red TFA-1 M-LNCS Sterile Sensors M-LNCS Reprocessed Sterile Sensors SpO2.com Sensors rainbow SpCO Disposable Sensors LNCS-II rainbow 8 Lambda RD rainbow 8 Lambda RD SET DBI DBI-dc LNCS DBI Red DBI M-LNCS DBI

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198