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

    FloPatch (FP110)

    K Number: K191388 · Decision Jun 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    FloPatch (FP110)
    K Number
    K191388
    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 (R/A 1929803 Ontario Corp.)
    Date Received
    May 24, 2019
    Decision Date
    June 21, 2019
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 (R/A 1929803 Ontario Corp.)

    K Number Device Name
    K200337 FloPatch (FP120)