LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K961289
    Device Name
    VAPOPHENE
    Manufacturer
    GERMIPHENE CORP.
    Date Cleared
    1997-12-04

    (609 days)

    Product Code
    MED
    Regulation Number
    880.6885
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in sterilizing dental and surgical instruments such as extractor forceps with sirrated handles, IRIS scissors, and convex mirrors and handles, with all legally marketed models of MDT Harvey Chemiclaves, when use of chemiclave solution is indicated, and used according to the chemiclave cycle parameters, ( 132°C, 20 -27 psi, for 20 minutes per cycle). Not for use in water or steam type sterilizers

    Device Description

    Vapophene - Chemical autoclave solution

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Vapophene - Chemical autoclave solution," but it does not detail any performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. It only states that the device is "substantially equivalent" to legally marketed predicate devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1