BEUDAMED
    FDA Registration Active 🇺🇸 United States

    M4576B Gentle Care Cuff, Adult XL

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016618143
    FEI Number
    3016618143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US

    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

    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

    Develop Specifications But Do Not Manufacture At This Facility