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

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    K Number: K070594 · Decision Aug 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    12
    Review Days
    152

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    Basic Information

    Device Name
    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
    K Number
    K070594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulmonetic Systems, Inc.
    Date Received
    March 2, 2007
    Decision Date
    August 1, 2007
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Pulmonetic Systems, Inc.

    K Number Device Name
    K083688 PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
    K060647 LTV 1200 VENTILATOR
    K060549 AUTOMOBILE LIGHTER POWER CORD
    K051767 LTV 1000 VENTILATOR
    K040790 MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
    K040540 MODIFICATION TO LTV 1000 VENTILATOR
    K032226 LTV-1000 VENTILATOR
    K010608 MODIFICATION TO LAP TOP VENTILATOR (LTV)
    K002881 VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
    K984056 LTV 1000
    Search all 12 clearances from Pulmonetic Systems, Inc. →