BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Peak.me

    K Number: K180487 · Decision Oct 26, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    245

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    Basic Information

    Device Name
    Peak.me
    K Number
    K180487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Breathe Me, Ltd.
    Date Received
    February 23, 2018
    Decision Date
    October 26, 2018
    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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