LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971318
    Device Name
    MM-1 MOVEMENT MONITOR
    Manufacturer
    AXON INSTRUMENTS, INC.
    Date Cleared
    1997-07-28

    (110 days)

    Product Code
    GYD,84G
    Regulation Number
    882.1950
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MM-1 MOVEMENT MONITOR

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

    The MM-1 provides useful, quantitative measurements of several neurologically relevant movement phenomena: tremor, dexterity and reaction/movement time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.

    Device Description

    Movement Monitor (MM-1)

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria, study details, and performance of the Movement Monitor (MM-1).

    The document is a 510(k) clearance letter from the FDA, which indicates that the device has been found substantially equivalent to a predicate device. It defines the device's indications for use but does not include the specific study data, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment details you are looking for. These details are typically found in the 510(k) summary or the full 510(k) submission, which is not provided here.

    Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1