BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Expression IP5 Information Portal

    Reg #: 3016701404 · FEI: 3016701404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    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
    K131382

    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

    Expression IP5 Information Portal Expression MR200 MRI Patient Monitoring System NiBP Cuff, Single Lumen, Neo #2, Disp - 989803183181 Wireless SpO2 Patient Module - 989803183541 NiBP Cuff, Single Lumen, Adult - 989803182641 NiBP Cuff, Single Lumen, Infant #5, Disp - 989803183211 NiBP Cuff, Single Lumen, Lrg Adult-L - 989803182671 NiBP Cuff, Single Lumen, Infant - 989803182611 NiBP Cuff, Single Lumen, Sample Kit,Disp - 989803182591 NiBP Cuff, Single Lumen, Pediatric - 989803182621 NiBP Cuff, Single Lumen, Small Adult, Disp - 989803182531 Advanced Apps ECG Cable - 989803176381 NiBP Cuff, Single Lumen, Thigh - 989803182681 NiBP Cuff, Single Lumen, Neo #1, Disp - 989803183171 NiBP Cuff, Single Lumen, Adult-L - 989803182651 NiBP Cuff, Single Lumen,Lrg Adult-L,Disp - 989803182571 NiBP Cuff, Single Lumen, Small Adult - 989803182631 NiBP Cuff, Single Lumen, Lrg Adult, Disp - 989803182561 NiBP Cuff, Single Lumen, Thigh, Disp - 989803182581 Expression IP5 Software Upgrade - 989803197491 NiBP Cuff, Single Lumen, Neo #3, Disp - 989803183191 NiBP Cuff, Single Lumen, Adult-L, Disp - 989803182551 NiBP Cuff, Single Lumen, Pediatric, Disp - 989803182521 Expression MR Wireless ECG Patient Module - 989803183661 NiBP Cuff, Single Lumen, Neo #4, Disp - 989803183201 NiBP Cuff, Single Lumen, Adult, Disp - 989803182541 NiBP Cuff, Single Lumen, Lrg Adult - 989803182661 NiBP Cuff, Single Lumen, Infant, Disp - 989803182511 Expression MR200 New MRI Monitor Accessories - 866177

    Establishment Types

    Repack or Relabel Medical Device