BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PulmoScan

    Reg #: 3017200972 · FEI: 3017200972 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COGNITA LABS LLC
    Registration Number
    3017200972
    FEI Number
    3017200972
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 N MAIN ST, STE C1
    City
    Santa Ana
    State
    CA
    ZIP
    92701
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191876

    Owner / Operator

    Firm Name
    Cognita Labs LLC
    Operator Number
    10076939
    Address
    700 N MAIN ST, STE C1
    City
    Santa Ana
    State
    CA
    Postal Code
    92701
    Country
    US
    Correspondent
    Gaurav Patel

    Products

    Device Name Product Code
    Impedance Measuring Device Utilizing Oscillation Techniques PNV

    Proprietary Names

    PulmoScan

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198