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510(k) Data Aggregation

    K Number
    K972795
    Device Name
    CARDIO-CARD MANAGEMENT SYSTEM II
    Manufacturer
    NASIFF ASSOC., INC.
    Date Cleared
    1998-02-20

    (207 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARDIO-CARD MANAGEMENT SYSTEM II

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

    The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.

    Device Description

    Cardio-Card Management System II

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria. The document is a 510(k) clearance letter from the FDA for the Cardio-Card Management System II, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters and indications for use but does not contain details about performance studies, acceptance criteria, or ground truth establishment.

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