BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ANTI-ARRHYTHMIC CONTROL LEVELS I & II

    K Number: K811809 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    201
    Applicant Total
    15
    Review Days
    15

    Basic Information

    Device Name
    ANTI-ARRHYTHMIC CONTROL LEVELS I & II
    K Number
    K811809
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    ENVIRONMENTAL CHEMICAL SPECIALTIES
    Date Received
    June 25, 1981
    Decision Date
    July 10, 1981
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DIF Drug Mixture Control Materials

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