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510(k) Data Aggregation

    K Number
    K091178
    Device Name
    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
    Manufacturer
    MTP MEDICAL TECHNICAL PROMOTION GMBH
    Date Cleared
    2009-07-31

    (100 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 :

    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN

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

    MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen are intended to cover equipment used in medical settings in order to maintain a sterile field and as an aid in the clean up of equipment after surgery. The covers are not intended to be used as patient drapes and have no patient contact.

    Device Description

    MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "MTP Disposable Equipment Covers, KARL STORZ 15'' Touch Screen." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is about the regulatory clearance process for a non-active, disposable cover, not the performance evaluation of a diagnostic or therapeutic AI-powered device.

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