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

    COMFORT TWIN NASAL MASK

    K Number: K091066 · Decision Sep 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    21
    Review Days
    142

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    Basic Information

    Device Name
    COMFORT TWIN NASAL MASK
    K Number
    K091066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Inc., Sleep & Home Respiratory Group
    Date Received
    April 14, 2009
    Decision Date
    September 3, 2009
    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 Respironics Inc., Sleep & Home Respiratory Group

    K Number Device Name
    K092835 COMFORTGEL NASAL MASK
    K092648 RESPIRONICS PERFORMAX SE TOTAL FACE MASK
    K090539 BIPAP AUTOSV ADVANCED
    K091191 GAS TRANSFILL
    K091843 COMFORT TWIN NASAL MASK
    K091319 REMSTAR AUTO A-FLEX
    K090484 ALICE PDX
    K091271 RESPIRONICS PERFORMAX TOTAL FACE MASK
    K090243 REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
    K083526 TRILOGY 100 VENTILATOR
    Search all 21 clearances from Respironics Inc., Sleep & Home Respiratory Group →