BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ULTRAMAX/MODEL NUMBER A1

    K Number: K960044 · Decision Aug 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    213

    Basic Information

    Device Name
    ULTRAMAX/MODEL NUMBER A1
    K Number
    K960044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Entlab OY
    Date Received
    January 2, 1996
    Decision Date
    August 2, 1996
    Product Code
    LWI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWI Ultrasound, Sinus

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