BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    M4576B Gentle Care Cuff, Adult XL

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K071885

    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
    Antimicrobial Blood Pressure Cuff OED

    Proprietary Names

    M4576B Gentle Care Cuff, Adult XL M4553B Easy Care Cuff, 1 Hose, Pediatric (1) M4558B Easy Care Cuff Lrg Adult XL M4573B Gentle Care Cuff Pediatric M4552B Easy Care Cuff, 1 Hose, Infant (1) 989803182301 Single Care Cuff, Adult 989803182321 Single Care Cuff, Large Adult 989803182311 Single Care Cuff, Adult XL 989803182281 Single Care Cuff, Pediatric 989803182291 Single Care Cuff, Small Adult M4575B Gentle Care Cuff Adult M4559B Easy Care Cuff Thigh M4577B Gentle Care Cuff Large Adult M4572B Gentle Care Cuff Infant M4556B Easy Care Cuff Adult XL M4555B Easy Care Cuff Adult M4554B Easy Care Cuff Sm Adult M4574B Gentle Care Cuff Small Adult M4578B Gentle Care Cuff, Large Adult XL M4557B Easy Care Cuff Lrg Adult

    Establishment Types

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