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

    NASAL INTERFACE MODEL 7910

    K Number: K974453 · Decision Aug 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    9
    Review Days
    252

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    Basic Information

    Device Name
    NASAL INTERFACE MODEL 7910
    K Number
    K974453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthdyne Technologies, Inc.
    Date Received
    November 25, 1997
    Decision Date
    August 4, 1998
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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