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

    SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS

    K Number: K983980 · Decision Nov 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    395
    Applicant Total
    519
    Review Days
    7

    Basic Information

    Device Name
    SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
    K Number
    K983980
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Received
    November 9, 1998
    Decision Date
    November 16, 1998
    Product Code
    DSI
    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
    DSI Detector And Alarm, Arrhythmia

    Similar 510(k) Clearances

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

    Zio AT® device (A100A1001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SmartCardia 7L Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unified Arrhythmia Diagnostic System PocketECG IV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BodyGuardian Remote Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Patient Assistant Model PA97000

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

    Other Clearances by SIEMENS MEDICAL SOLUTIONS USA, INC.

    K Number Device Name
    K163284 syngo. CT Neuro Perfusion
    K163294 syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
    K162302 Somatom Confidence ® RT Pro
    K162971 Multix Fusion Max
    K153447 MAGNETOM Spectra
    K151765 SOMATOM Perspective
    K153244 Cios Fusion
    K160426 syngo.via MI Workflows
    K160317 syngo.via MI Workflows
    K153232 Cios Select
    Search all 519 clearances from SIEMENS MEDICAL SOLUTIONS USA, INC. →