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510(k) Data Aggregation

    K Number
    K012498
    Device Name
    DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
    Manufacturer
    PULSE METRIC, INC.
    Date Cleared
    2001-11-01

    (90 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K050680
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DynaPulse 500G is indicated for trained medical professionals to operate on partient at clinical settings to collect and measure blood pressure, pulser and pressure waveform information. In addition, the Dyllar uise 2000 is marcated to purchase week on the device does not send any administrate this device upon present and experience are required to check and interpret the information delivered.

    Device Description

    DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the DynaPulse Model DP500G Non-Invasive Blood Pressure Monitor. It does not contain the specific information requested about acceptance criteria, study details, or ground truth establishment. It primarily focuses on the regulatory approval and substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information from the provided text.

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