BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    K4 Portable Metabolic Measurement

    Reg #: 8021084 · FEI: 2995 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COSMED S.R.L.
    Registration Number
    8021084
    FEI Number
    2995
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA DEI PIANI DI MONTE, SAVELLO 37
    City
    ALBANO LAZIALE, ROMA
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K963373

    Owner / Operator

    Firm Name
    COSMED S.R.L.
    Operator Number
    8021084
    Address
    VIA DEI PIANI DI MONTE, SAVELLO 37
    City
    ALBANO LAZIALE, ROMA
    State
    IT-NOTA
    Postal Code
    00041
    Country
    IT

    US Agent

    Business Name
    Schiff & Company
    Contact Name
    Thomas Padula
    Address
    583 Mountain Avenue
    City
    North Caldwell
    State
    NJ
    ZIP
    07006
    Country
    US
    Email
    [email protected]
    Phone
    201 3178810

    Products

    Device Name Product Code
    Calculator, Pulmonary Function Data BZC

    Proprietary Names

    K4 Portable Metabolic Measurement

    Establishment Types

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