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

    ROCHE SENSOR ADAPTOR

    K Number: K791559 · Decision Nov 21, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    16
    Review Days
    96

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    Basic Information

    Device Name
    ROCHE SENSOR ADAPTOR
    K Number
    K791559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Roche Medical Electronics, Inc.
    Date Received
    August 17, 1979
    Decision Date
    November 21, 1979
    Product Code
    KLK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

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    Other Clearances by Roche Medical Electronics, Inc.

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    K791035 FETASONDE FETAL ACTIVITY MONITOR
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