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

    NEV-10 NEGATIVE PRESSURE VENTILATOR

    K Number: K910947 · Decision Jun 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    20
    Review Days
    89

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    Basic Information

    Device Name
    NEV-10 NEGATIVE PRESSURE VENTILATOR
    K Number
    K910947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Lifecare Services, Inc.
    Date Received
    March 6, 1991
    Decision Date
    June 3, 1991
    Product Code
    BYT
    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
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

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