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510(k) Data Aggregation

    K Number
    K970885
    Device Name
    ULTRASOUND SYSTEMS DRAPE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-09-22

    (195 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRASOUND SYSTEMS DRAPE

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

    Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Ultrasound Systems Drape Kit." This document explains the FDA's decision regarding substantial equivalence and the regulatory classification of the device.

    It does not contain any information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.

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