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510(k) Data Aggregation

    K Number
    K022156
    Device Name
    LATEX ULTRASONIC PROBE COVER
    Manufacturer
    PLEASURE LATEX PRODUCTS SDN. BHD.
    Date Cleared
    2003-09-11

    (436 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LATEX ULTRASONIC PROBE COVER

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

    The [ SURE™ ] probe cover is intended to be placed on Ultrasound Probes used in natural body orifices such as vagina to facilitate cleaning and sanitization of the probe.

    Device Description

    SURE ™ Latex Ultrasonic Probe Cover

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "SURE™ Latex Ultrasonic Probe Cover". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, not performance metrics derived from a study.

    Therefore, I cannot provide the requested information based on this document.

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