BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62

    K Number: K203383 · Decision Dec 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    202
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
    K Number
    K203383
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Consumer Lifestyle - Innovation Site Eindhoven
    Date Received
    November 17, 2020
    Decision Date
    December 15, 2020
    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 Philips Consumer Lifestyle - Innovation Site Eindhoven

    K Number Device Name
    K201381 Philips Avent Single/Double electric breast pump Advanced