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

    VERSAFLEX(TM) DELTA ST(TM) MONITOR

    K Number: K863922 · Decision Oct 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    190
    Applicant Total
    2
    Review Days
    12

    Basic Information

    Device Name
    VERSAFLEX(TM) DELTA ST(TM) MONITOR
    K Number
    K863922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    VERSAFLEX DELIVERY SYSTEMS, INC.
    Date Received
    October 8, 1986
    Decision Date
    October 20, 1986
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

    Similar 510(k) Clearances

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

    AeviceMD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AT-Patch (ATP-C130/ATP-C70)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HiCardi+ H100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    S-Patch (S-Patch ExL)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ABPMpro

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Carnation Ambulatory Monitor

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

    Other Clearances by VERSAFLEX DELIVERY SYSTEMS, INC.

    K Number Device Name
    K862937 BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE