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510(k) Data Aggregation

    K Number
    K013976
    Device Name
    BOEHRINGER MRI SUCTION REGULATORY
    Manufacturer
    BOEHRINGER LABORATORIES
    Date Cleared
    2002-01-08

    (36 days)

    Product Code
    KDP
    Regulation Number
    880.6740
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    KDP

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

    The Bochringer MRI Suction Regulators are designed to provide accurate control of wall suction for use in suction therapy procedures in an MRI environment.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Boehringer MRI Suction Regulator, stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain any information regarding acceptance criteria, device performance, statistical studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and compliance.

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