BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    iCertainty

    K Number: K181269 · Decision Dec 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    1
    Review Days
    214

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    Basic Information

    Device Name
    iCertainty
    K Number
    K181269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rfpi
    Date Received
    May 14, 2018
    Decision Date
    December 14, 2018
    Product Code
    DPW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    SU
    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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