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

    MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV

    K Number: K962517 · Decision Feb 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    46
    Applicant Total
    9
    Review Days
    238

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    Basic Information

    Device Name
    MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
    K Number
    K962517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthdyne Technologies, Inc.
    Date Received
    June 27, 1996
    Decision Date
    February 20, 1997
    Product Code
    MNS
    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
    MNS Ventilator, Continuous, Non-Life-Supporting

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