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

    CARDIO TEAM II

    K Number: K962937 · Decision Apr 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    292
    Applicant Total
    2
    Review Days
    255

    Basic Information

    Device Name
    CARDIO TEAM II
    K Number
    K962937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VISION ELECTRONICS
    Date Received
    July 29, 1996
    Decision Date
    April 10, 1997
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

    Similar 510(k) Clearances

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

    VitalSigns 1-Lead Holter (VSH101)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QT ECG (QTERD100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V-Patch Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QT ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KardiaMobile 6L

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

    Other Clearances by VISION ELECTRONICS

    K Number Device Name
    K963375 CARDIACMONITOR