BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

    K Number: K253166 · Decision Apr 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    5
    Review Days
    215

    Basic Information

    Device Name
    F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
    K Number
    K253166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BMC Medical Co., Ltd.
    Date Received
    September 26, 2025
    Decision Date
    April 29, 2026
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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