BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Quick Connect SpO2 Starter Kit - 989803167111

    Reg #: 3016701404 · FEI: 3016701404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016701404
    FEI Number
    3016701404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Corporate Lane, STE B
    City
    Export
    State
    PA
    ZIP
    15632
    Country
    US

    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

    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

    Repack or Relabel Medical Device