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510(k) Data Aggregation

    K Number
    K061428
    Device Name
    PMP4 APPLICATION
    Manufacturer
    CARD GUARD SCIENTIFIC SURVIVAL, LTD.
    Date Cleared
    2006-10-16

    (146 days)

    Product Code
    MSX
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PMP4 APPLICATION

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

    The PMP4 Application is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the PMP4 Application, a network and communication physiological system. While it indicates the device is substantially equivalent to a predicate device and states its intended use, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9 based on the provided text. This document is a regulatory approval notice, not a study report.

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