BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202

    K Number: K800364 · Decision Mar 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    21

    Basic Information

    Device Name
    ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202
    K Number
    K800364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    HOFFREL INSTRUMENTS, INC.
    Date Received
    February 20, 1980
    Decision Date
    March 12, 1980
    Product Code
    DKX
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKX Thin Layer Chromatography, Barbiturate

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