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

    CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST

    K Number: K934193 · Decision Nov 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    29
    Applicant Total
    70
    Review Days
    85

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    Basic Information

    Device Name
    CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
    K Number
    K934193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4710
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biosearch Medical Products, Inc.
    Date Received
    August 26, 1993
    Decision Date
    November 19, 1993
    Product Code
    EOX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOX Esophagoscope (Flexible Or Rigid)

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