BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AliveCor

    Reg #: 3009715978 · FEI: 3009715978 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    34
    Establishment Types
    4
    Classifications
    7

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    Registration Details

    Registration Name
    AliveCor
    Registration Number
    3009715978
    FEI Number
    3009715978
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    189 N Bernardo Avenue, Suite 100
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181823

    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
    Medical Device Data System OUG
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph DPS
    Electrocardiograph Software For Over-The-Counter Use QDA
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Stethoscope, Electronic DQD

    Proprietary Names

    KardiaAI AliveCor Heart Monitor Universal Module AliveCor Heart Monitor AliveCor Heart Monitor for Samsung Galaxy S4 AliveCor Heart Monitor Universal AliveCor ECG AliveCor Heart Monitor for iPhone AliveCor ECG for iPhone AliveCor Heart Monitor for iPhone 4/4S AliveCor Heart Monitor for iPhone 5 KardiaMobile 6L Max KardiaMobile 6L K1000 Kardia 6L+ KARDIAMOBILE Corvair KAI 12L KardiaMobile Card KARDIAMOBILE 6L Kardia 12L Impala KardiaCore KardiaCore Application Kardia Mobile KardiaMobile OmronConnect KardiaBand Kardia Band Steth IO Spot AliveCor QT Service QT Service Algorithm Corvair Monza KAI 12L v2 KardiaAI2

    Establishment Types

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