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

    Cardiac Monitor 1500

    K Number: K191697 · Decision Feb 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    110
    Applicant Total
    2
    Review Days
    241

    Basic Information

    Device Name
    Cardiac Monitor 1500
    K Number
    K191697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zynex Medical, Inc.
    Date Received
    June 25, 2019
    Decision Date
    February 21, 2020
    Product Code
    DSB
    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
    DSB Plethysmograph, Impedance

    Similar 510(k) Clearances

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

    SOZO Pro

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zynex Monitoring System, Model CM-1600

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bodyport Cardiac Scale

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOZO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOZO Body Fluid Analyzer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ReDS System

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

    Other Clearances by Zynex Medical, Inc.

    K Number Device Name
    K223217 Zynex Monitoring System, Model CM-1600