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

    RESUSCITATOR, PULMONARY, MANUAL

    K Number: K844729 · Decision Mar 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    29
    Review Days
    111

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    Basic Information

    Device Name
    RESUSCITATOR, PULMONARY, MANUAL
    K Number
    K844729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Life Design Systems, Inc.
    Date Received
    December 4, 1984
    Decision Date
    March 25, 1985
    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 Life Design Systems, Inc.

    K Number Device Name
    K913714 MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
    K885313 HUMIDI-FLEX TM
    K893030 CHILD SIZE - FILTER FLEX (TM)
    K892862 FLEX-CUP PERCUSSOR
    K892221 PULMONARY RESUSCITATOR, MODIFICATION
    K890011 OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
    K890108 MODIFIED CUSHION-FLEX(TM)
    K884387 CUSHION FLEX(TM)
    K884068 PULMANEX TM (NEO-NATAL SIZE)
    K873179 HEATER WIRE BREATHING CIRCUIT
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