BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Electro Flo 6 Airway Clearance System

    K Number: K201490 · Decision Feb 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    253

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    Basic Information

    Device Name
    Electro Flo 6 Airway Clearance System
    K Number
    K201490
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Med Systems, Inc.
    Date Received
    June 4, 2020
    Decision Date
    February 12, 2021
    Product Code
    BYI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BYI Percussor, Powered-Electric

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