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510(k) Data Aggregation

    K Number
    K940954

    Validate with FDA (Live)

    Device Name
    SYNAPTIC 3000
    Manufacturer
    THE SYNAPTIC CORP.
    Date Cleared
    1997-06-20

    (1207 days)

    Product Code
    GZJ,84G
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Synaptic 3000". It does not contain information about acceptance criteria, device performance details, study design, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.

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