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

    DISPOSABLE MANUAL RESUSCITATOR

    K Number: K943617 · Decision Aug 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    4
    Review Days
    15

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    Basic Information

    Device Name
    DISPOSABLE MANUAL RESUSCITATOR
    K Number
    K943617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Puritan-Bennett
    Date Received
    July 27, 1994
    Decision Date
    August 11, 1994
    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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    Other Clearances by Puritan-Bennett

    K Number Device Name
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    K935784 PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM
    K942246 PURITAN-BENNETT NASAL CPAP MASK