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

    DEMISTIFIER ISOLATION CHAMBER

    K Number: K902161 · Decision Oct 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    3
    Review Days
    153

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    Basic Information

    Device Name
    DEMISTIFIER ISOLATION CHAMBER
    K Number
    K902161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Peace Medical, Inc.
    Date Received
    May 15, 1990
    Decision Date
    October 15, 1990
    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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