BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AliveCor Heart Monitor Universal Module

    Reg #: 3009715978 · FEI: 3009715978 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    AliveCor
    Registration Number
    3009715978
    FEI Number
    3009715978
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    189 N Bernardo Avenue, Suite 100
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130409

    Owner / Operator

    Firm Name
    AliveCor, Inc.
    Operator Number
    10041430
    Address
    189 N Bernardo Avenue, Suite 100
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US
    Correspondent
    Samip Shah

    Products

    Device Name Product Code
    Electrocardiograph DPS

    Proprietary Names

    AliveCor Heart Monitor Universal Module AliveCor Heart Monitor AliveCor Heart Monitor Universal AliveCor Heart Monitor for Samsung Galaxy S4

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device