BEUDAMED
    FDA Registration Active 🇺🇸 United States

    eCARTv5

    Reg #: 3031823069 · FEI: 3031823069 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AGILEMD
    Registration Number
    3031823069
    FEI Number
    3031823069
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10080 N. Wolfe Rd., Suite SW3-229
    City
    Cupertino
    State
    CA
    ZIP
    95014
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233253

    Owner / Operator

    Firm Name
    AgileMD
    Operator Number
    10091218
    Address
    10080 N. Wolfe Rd., Suite SW3-229
    City
    Cupertino
    State
    CA
    Postal Code
    95014
    Country
    US
    Correspondent
    Borna Safabakhsh

    Products

    Device Name Product Code
    Medium-Term Adjunctive Predictive Cardiovascular Indicator QNL

    Proprietary Names

    eCARTv5 eCARTv5 Clinical Deterioration Suite eCART

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device