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

    CMI VACUUM DELIVERY SYSTEM #003C AND #004C

    K Number: K881306 · Decision Jun 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    4
    Review Days
    77

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    Basic Information

    Device Name
    CMI VACUUM DELIVERY SYSTEM #003C AND #004C
    K Number
    K881306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Challenge Mfg., Inc.
    Date Received
    March 28, 1988
    Decision Date
    June 13, 1988
    Product Code
    HDB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HDB Extractor, Vacuum, Fetal

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    Other Clearances by Challenge Mfg., Inc.

    K Number Device Name
    K910788 CMI TENDER TOUCH VE #303TT AND 404TT
    K895446 CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)
    K881967 CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)