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

    DV-300 Aspirator

    K Number: K181398 · Decision Jul 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    55

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    Basic Information

    Device Name
    DV-300 Aspirator
    K Number
    K181398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ding Hwa Co., Ltd.
    Date Received
    May 29, 2018
    Decision Date
    July 23, 2018
    Product Code
    JCX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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    Other Clearances by Ding Hwa Co., Ltd.

    K Number Device Name
    K140809 CLIQ DV-300 ASPIRATOR
    K140031 SUCTION PUMP
    K132308 CLIQ DV-300 ASPIRATOR
    K080005 SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701