LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970163
    Device Name
    ALPHA MX (20)/ULTRA PC (30)
    Manufacturer
    TECHNICAL MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-12-10

    (328 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHNICAL MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1