LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982371
    Device Name
    MEDCO ASPIRATOR IV
    Manufacturer
    MEDCO MFG.
    Date Cleared
    1999-02-12

    (220 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A portable, AC powered suction pump to be used to remove infectious materials from wounds or fluids from a patients airway or respiratory Support system. The pump may be used during Surgery! • the operating room or at the patient bedside. The device includes a microbial

    Device Description

    A portable, AC powered suction pump

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Medco Aspirator IV, specifically from pages 0, 1, and 2, does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlining regulatory information. It does not include the detailed technical study information you are requesting.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1