BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    ACCURKARDIA INC.

    · Expires 2026
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ACCURKARDIA INC.
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101 Avenue Of The Americas Ste 931
    City
    New York
    State
    NY
    ZIP
    10013
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252361

    Owner / Operator

    Firm Name
    AccurKardia Inc.
    Operator Number
    10095995
    Address
    101 Avenue of Americas, Suite 931
    City
    New York
    State
    NY
    Postal Code
    10013
    Country
    US
    Correspondent
    Juan Jimenez

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    AccurECG Analysis System (v2)

    Establishment Types

    Manufacture Medical Device