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

    TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300

    K Number: K802978 · Decision Feb 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    73

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    Basic Information

    Device Name
    TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
    K Number
    K802978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Brattle Instrument Corp.
    Date Received
    November 21, 1980
    Decision Date
    February 2, 1981
    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 Brattle Instrument Corp.

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    K770295 ABDOMINAL ECG PROCESSOR FOR FETAL MONI.
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