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

    PTR MK II VENTILATOR

    K Number: K860692 · Decision May 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    28
    Review Days
    85

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    Basic Information

    Device Name
    PTR MK II VENTILATOR
    K Number
    K860692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    February 25, 1986
    Decision Date
    May 21, 1986
    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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