LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994175
    Device Name
    MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
    Manufacturer
    SODEM SYSTEMS
    Date Cleared
    1999-12-21

    (11 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K954717
    Why did this record match?
    Device Name :

    MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

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

    The Sodem High Speed System (with associated accessories/attachments) is intended for use for neuro surgery (spine and craniatomy) and median sternotomy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Sodem High Speed System. It does not contain information about acceptance criteria, detailed study designs, or performance metrics. Therefore, I cannot extract the requested information from the provided text.

    The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing. It mentions "indications for use" and refers to general controls, but does not include specific efficacy or performance study details, acceptance criteria, or expert review processes.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1