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

    MODEL 1920 WASTE GAS SCAVENGER

    K Number: K963601 · Decision Apr 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    231

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    Basic Information

    Device Name
    MODEL 1920 WASTE GAS SCAVENGER
    K Number
    K963601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    G. Dundas Co.
    Date Received
    September 9, 1996
    Decision Date
    April 28, 1997
    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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