BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Quick Connect SpO2 Starter Kit - 989803167111

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Electronics Ltd
    Registration Number
    3000126629
    FEI Number
    3000126629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1875 Buckhorn Gate, 5th Floor
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K090785

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Shaylee Masilunas
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    724 8162019

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    Quick Connect SpO2 Starter Kit - 989803167111 Quick Connect SpO2 Grip, Adult, 20/box - 989803166551 Wireless ECG Module - 989803163121 ADVANCED FILTER ECG CABLE - 989803170121 Anesthetic Oxygen (O2) Sensor - 989803162051 Quick Connect SpO2 Clip, Adult - 989803166531 Quick Connect SpO2 Grip, Ped, 20/box - 989803166561 Quick Connect SpO2 Clip, Pediatric - 989803166541 Wireless SP02 Module (Gen 2) - 989803163111 Quick Connect SpO2 Grip, Infant, 20/box - 989803166571 CAB,4 LD,MRI ECG - 9224 Quick Connect SpO2 Grip, Neo, 20/box - 989803166581 Quick Connect SpO2 Probe, MRI - 989803161991 Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401 KIT,SAMPLE,AGENTS,3160 - 94018 SpO2 SENSOR GRIP INFANT/PEDIATRIC 2 PACK - 989803162511 Expression MR Cuff, Disp, NEO, MRI, Size #5 - 989803170421 CAB,4 LD,CV MRI ECG - 9223 CUFFF,CHILD,MRI,COLDER CONN - 989803169441 CAB,4 LD,NEO.MRI ECG - 9222 PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 - 94023 GRIP SENSOR STARTER KIT - 989803162491 SpO2 SENSOR GRIP ADULT/NEONATAL 2 PACK - 989803162501 MRI Patient Monitoring System, Mode

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device