BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SureTouch Mobile Pressure Mapping System

    Reg #: 3020798169 · FEI: 3020798169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sure, Inc.
    Registration Number
    3020798169
    FEI Number
    3020798169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    325 Manville Rd, Suite 4A
    City
    Pleasantville
    State
    NY
    ZIP
    10570
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181672

    Owner / Operator

    Firm Name
    Sure, Inc.
    Operator Number
    10057868
    Address
    655 Deep Valley Dr, Suite 200
    City
    Rolling Hills Estates
    State
    CA
    Postal Code
    90274
    Country
    US
    Correspondent
    David Ables

    Products

    Device Name Product Code
    System, Documentation, Breast Lesion NKA

    Proprietary Names

    SureTouch Mobile Pressure Mapping System Bexa Pressure Mapping System Model 1885 Bexa Pressure Mapping System: device, stand, phantom and scale, case, charger(s), and optional tablet display

    Establishment Types

    Manufacture Medical Device