BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    FORTUNE SILICONE VACUUM SUCTION, MODEL #1300

    K Number: K021193 · Decision Feb 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    303

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    Basic Information

    Device Name
    FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
    K Number
    K021193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4340
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fortune Medical Instrument Corp.
    Date Received
    April 15, 2002
    Decision Date
    February 12, 2003
    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 Fortune Medical Instrument Corp.

    K Number Device Name
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    K014002 ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
    K980917 ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
    K980919 ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER