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

    Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

    K Number: K163609 · Decision Jun 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
    K Number
    K163609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pall International Sarl
    Date Received
    December 22, 2016
    Decision Date
    June 1, 2017
    Product Code
    NHV
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NHV System, Water Purification, General Medical Use

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    Other Clearances by Pall International Sarl

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