LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982635
    Device Name
    CAREDOP II
    Manufacturer
    NICOLET BIOMEDICAL
    Date Cleared
    1998-08-07

    (25 days)

    Product Code
    JAF
    Regulation Number
    892.1540
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Monitoring of blood flow in veins and arteries to assist in the detection of vascular disease and detection of early fetal heartbeat Instrument used in doctor's office, clinic or hospital, by use for on the order of a physician.

    The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Nicolet Vascular Inc. CareDop II. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1