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

    PIONEER U601 SERIES ASPIRATOR

    K Number: K052650 · Decision Nov 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    19
    Review Days
    39

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    Basic Information

    Device Name
    PIONEER U601 SERIES ASPIRATOR
    K Number
    K052650
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merits Health Products Co., Ltd.
    Date Received
    September 26, 2005
    Decision Date
    November 4, 2005
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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