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510(k) Data Aggregation

    K Number
    K972022
    Device Name
    ZAK-2000
    Manufacturer
    CARDIO SYSTEMS, INC.
    Date Cleared
    1998-01-22

    (234 days)

    Product Code
    FNM,DAT
    Regulation Number
    880.5550
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZAK-2000

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

    FOR The PREVENTION AND TREAT M [sic] PRESSURE ULCERS OF [sic]

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ZAK-2000" for the prevention and treatment of pressure ulcers. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot fulfill your request based on the given input.

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