BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hook-Up Kits (Holter Kits)

    Reg #: 3004531359 · FEI: 3004531359 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DANLEE MEDICAL PRODUCTS, INC.
    Registration Number
    3004531359
    FEI Number
    3004531359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BLDG. 5, 6075 EAST MOLLOY RD.
    City
    Mattydale
    State
    NY
    ZIP
    13211
    Country
    US

    Regulatory Submissions

    510(k) Number
    K931457

    Owner / Operator

    Firm Name
    DANLEE MEDICAL PRODUCTS, INC.
    Operator Number
    9067459
    Address
    BLDG. 5, 6075 EAST MOLLOY RD., --
    City
    Syracuse
    State
    NY
    Postal Code
    13211
    Country
    US
    Correspondent
    JONI L WALTON

    Products

    Device Name Product Code
    Electrode, Electrocardiograph DRX

    Proprietary Names

    Hook-Up Kits (Holter Kits)

    Establishment Types

    Repack or Relabel Medical Device