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

    FlowMet-R

    K Number: K182494 · Decision Feb 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    2
    Review Days
    169

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    Basic Information

    Device Name
    FlowMet-R
    K Number
    K182494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laser Associated Sciences, Inc.
    Date Received
    September 11, 2018
    Decision Date
    February 27, 2019
    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 Laser Associated Sciences, Inc.

    K Number Device Name
    K192966 FlowMet