BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CELLTRAK-B

    K Number: K834585 · Decision May 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    4
    Applicant Total
    79
    Review Days
    125

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    Basic Information

    Device Name
    CELLTRAK-B
    K Number
    K834585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6775
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    R&D Systems, Inc.
    Date Received
    December 29, 1983
    Decision Date
    May 2, 1984
    Product Code
    FRZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRZ Device, Patient Transfer, Powered

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