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

    Early Bird Bleed Monitoring System

    K Number: DEN180021 · Decision Mar 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    312

    Basic Information

    Device Name
    Early Bird Bleed Monitoring System
    K Number
    DEN180021
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1345
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Saranas, Inc.
    Date Received
    April 23, 2018
    Decision Date
    March 1, 2019
    Product Code
    QFJ
    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
    QFJ Intravascular Bleed Monitor

    Similar 510(k) Clearances

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    Saranas Early Bird Bleed Monitoring System

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