Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023569
    Date Cleared
    2002-11-04

    (11 days)

    Product Code
    Regulation Number
    870.1025
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Siemens INFINITY MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.

    Device Description

    The INFINITY MultiView WorkStation (MVWS) software version VF3 modifications include: Waveform Export, Calipers, Selected Strip Report, and Second SpO2 and Pulse Parameter Support.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the INFINITY MultiView WorkStation, detailing its trade name, common name, classification, legally marketed predicate devices, device description (including new features like Waveform Export, Calipers, Selected Strip Report, and Second SpO2 and Pulse Parameter Support), and intended use. The document explicitly states "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable," which indicates that a detailed clinical study with performance metrics and acceptance criteria was not part of this 510(k) submission. Therefore, I cannot generate the requested table and study details from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1