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

    ARDO Bellis

    K Number: K230590 · Decision Mar 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    ARDO Bellis
    K Number
    K230590
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ardo Medical AG
    Date Received
    March 3, 2023
    Decision Date
    March 30, 2023
    Product Code
    HGX
    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
    HGX Pump, Breast, Powered

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    Other Clearances by Ardo Medical AG

    K Number Device Name
    K212773 ARDO Alyssa
    K172067 One Mum Pumpset
    K150721 ARDO Calypso Pro Powered Breast Pump
    K141742 ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
    K011601 ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX