BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FloPatch FP120

    K Number: K223843 · Decision May 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    4
    Review Days
    132

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    Basic Information

    Device Name
    FloPatch FP120
    K Number
    K223843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Flosonics Medical
    Date Received
    December 22, 2022
    Decision Date
    May 3, 2023
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Flosonics Medical

    K Number Device Name
    K252810 FloPatch FP120
    K251114 FloPatch FP120
    K222242 FloPatch FP120