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

    PEAK FLOWMETERS FOR SPIROMETRY

    K Number: K851265 · Decision Oct 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    7
    Review Days
    214

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    Basic Information

    Device Name
    PEAK FLOWMETERS FOR SPIROMETRY
    K Number
    K851265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Solcoor, Inc.
    Date Received
    March 29, 1985
    Decision Date
    October 29, 1985
    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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