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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

    K Number: K011601 · Decision Jun 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX
    K Number
    K011601
    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
    Ardo Medical AG
    Date Received
    May 24, 2001
    Decision Date
    June 8, 2001
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    Y

    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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    Other Clearances by Ardo Medical AG

    K Number Device Name
    K230590 ARDO Bellis
    K212773 ARDO Alyssa
    K172067 One Mum Pumpset
    K150721 ARDO Calypso Pro Powered Breast Pump
    K141742 ARDO CARUM AND CALYPSO POWERED BREAST PUMPS