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

    Saranas Early Bird Bleed Monitoring System

    K Number: K230273 · Decision May 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    114

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    Basic Information

    Device Name
    Saranas Early Bird Bleed Monitoring System
    K Number
    K230273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1345
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Saranas, Inc.
    Date Received
    January 31, 2023
    Decision Date
    May 25, 2023
    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

    Other 510(k) clearances with the same product code (QFJ), ordered by most recent decision date.

    Early Bird Bleed Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Saranas, Inc.

    K Number Device Name
    DEN180021 Early Bird Bleed Monitoring System