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

    Peak flow meter

    K Number: K203196 · Decision May 26, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    210

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    Basic Information

    Device Name
    Peak flow meter
    K Number
    K203196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Sonmol Medical Equipment Co., Ltd.
    Date Received
    October 28, 2020
    Decision Date
    May 26, 2021
    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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