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

    FRASER HARLAKE NITRONOX SCAVENGER

    K Number: K821744 · Decision Jun 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    9
    Review Days
    11

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    Basic Information

    Device Name
    FRASER HARLAKE NITRONOX SCAVENGER
    K Number
    K821744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fraser Harlake, Inc.
    Date Received
    June 14, 1982
    Decision Date
    June 25, 1982
    Product Code
    CBN
    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
    CBN Apparatus, Gas-Scavenging

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