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

    CAPTUS 2000 WEL COUNTER

    K Number: K930962 · Decision May 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    29
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    CAPTUS 2000 WEL COUNTER
    K Number
    K930962
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1320
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Capintec Instruments, Inc.
    Date Received
    February 24, 1993
    Decision Date
    May 18, 1993
    Product Code
    IZD
    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
    IZD Probe, Uptake, Nuclear

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