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

    REMSTAR AFLEX CPAP SYSTEM

    K Number: K063830 · Decision Mar 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    21
    Review Days
    73

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    Basic Information

    Device Name
    REMSTAR AFLEX CPAP SYSTEM
    K Number
    K063830
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Inc., Sleep & Home Respiratory Group
    Date Received
    December 26, 2006
    Decision Date
    March 9, 2007
    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
    K091066 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
    Search all 21 clearances from Respironics Inc., Sleep & Home Respiratory Group →