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

    INFANT FLOW NCPAP MASKS

    K Number: K984254 · Decision Feb 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    26
    Review Days
    89

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    Basic Information

    Device Name
    INFANT FLOW NCPAP MASKS
    K Number
    K984254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sensor Medics Corp.
    Date Received
    November 27, 1998
    Decision Date
    February 24, 1999
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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    Other Clearances by Sensor Medics Corp.

    K Number Device Name
    K032516 HIOX80 AEROSOL ADAPTER
    K031745 INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
    K031883 LYRA NASAL MASK
    K030943 MODIFICATION TO HIOX
    K022192 PEGASUS NASAL CPAP SYSTEM
    K020665 HI-OX
    K012085 SOMNO STAR & SERIES SLEEP SYSTEM
    K012034 MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
    K991972 INFANT FLOW SYSTEM
    K981366 STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
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