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

    INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR

    K Number: K981307 · Decision Jul 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    3
    Review Days
    87

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    Basic Information

    Device Name
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
    K Number
    K981307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Respiratory Systems, Inc.
    Date Received
    April 10, 1998
    Decision Date
    July 6, 1998
    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 International Respiratory Systems, Inc.

    K Number Device Name
    K981308 INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
    K923618 PEEP VALVE