BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇳🇱 Netherlands

    PHILIPS PRE-FILTER OPTION

    K Number: K923141 · Decision Jan 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    111
    Review Days
    206

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    Basic Information

    Device Name
    PHILIPS PRE-FILTER OPTION
    K Number
    K923141
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems, Inc.
    Date Received
    June 29, 1992
    Decision Date
    January 21, 1993
    Product Code
    ITY
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

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