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

    JAYCO HYDROGEN MONITOR

    K Number: K882499 · Decision Jun 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    11

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    Basic Information

    Device Name
    JAYCO HYDROGEN MONITOR
    K Number
    K882499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1820
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Enteron, Inc.
    Date Received
    June 17, 1988
    Decision Date
    June 28, 1988
    Product Code
    NRH
    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
    NRH System, Breath Measurement

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