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

    Breezing Med

    K Number: K200076 · Decision Sep 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    255

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    Basic Information

    Device Name
    Breezing Med
    K Number
    K200076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tf Health Co.
    Date Received
    January 14, 2020
    Decision Date
    September 25, 2020
    Product Code
    BZL
    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
    BZL Computer, Oxygen-Uptake

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