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

    WALLABY 4

    K Number: K070180 · Decision May 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    21
    Review Days
    119

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    Basic Information

    Device Name
    WALLABY 4
    K Number
    K070180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Respironics Inc., Sleep & Home Respiratory Group
    Date Received
    January 19, 2007
    Decision Date
    May 18, 2007
    Product Code
    LBI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LBI Unit, Neonatal Phototherapy

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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 →