BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LASER ALIGNMENT TOOL

    K Number: K943381 · Decision Aug 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    27
    Applicant Total
    71
    Review Days
    27

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    Basic Information

    Device Name
    LASER ALIGNMENT TOOL
    K Number
    K943381
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5780
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    July 13, 1994
    Decision Date
    August 9, 1994
    Product Code
    IWE
    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
    IWE Monitor, Patient Position, Light-Beam

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