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

    RNA MEDICAL TONOMETER

    K Number: K922386 · Decision Jun 26, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    49
    Review Days
    37

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    Basic Information

    Device Name
    RNA MEDICAL TONOMETER
    K Number
    K922386
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bionostics, Inc.
    Date Received
    May 20, 1992
    Decision Date
    June 26, 1992
    Product Code
    LCH
    Advisory Committee
    Clinical Chemistry
    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
    LCH Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

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