BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550

    K Number: K942683 · Decision Nov 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550
    K Number
    K942683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionaire Corp.
    Date Received
    June 7, 1994
    Decision Date
    November 28, 1994
    Product Code
    FRF
    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
    FRF Cleaner, Air, Medical Recirculating

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    Other Clearances by Bionaire Corp.

    K Number Device Name
    K942434 BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER