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

    Peak Flow Meter (PF-10(BR-PEF231))

    K Number: K252802 · Decision May 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    268

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    Basic Information

    Device Name
    Peak Flow Meter (PF-10(BR-PEF231))
    K Number
    K252802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Bi-Rich Medical Devices Co., Ltd.
    Date Received
    September 3, 2025
    Decision Date
    May 29, 2026
    Product Code
    BZH
    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
    BZH Meter, Peak Flow, Spirometry

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