LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K955477
    Device Name
    HI-TEC CO2 INSUFFLATOR TYPE 1300
    Manufacturer
    HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ
    Date Cleared
    1997-08-06

    (615 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    CO2 Laparoscopic Insufflator type 1300

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a CO2 Laparoscopic Insufflator. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot answer the request based on the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1