BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    SONIC PALPOMETER

    K Number: K060125 · Decision Mar 16, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    57

    Basic Information

    Device Name
    SONIC PALPOMETER
    K Number
    K060125
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PALPOMETER SYSTEMS, INC.
    Date Received
    January 18, 2006
    Decision Date
    March 16, 2006
    Product Code
    IKE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IKE Transducer, Miniature Pressure

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