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

    HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR

    K Number: K964719 · Decision Feb 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    15
    Review Days
    88

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    Basic Information

    Device Name
    HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
    K Number
    K964719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hudson Respiratory Care, Inc.
    Date Received
    November 25, 1996
    Decision Date
    February 21, 1997
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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