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

    HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300

    K Number: K925566 · Decision Mar 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    499

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    Basic Information

    Device Name
    HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300
    K Number
    K925566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Holmes Products Corp.
    Date Received
    November 3, 1992
    Decision Date
    March 17, 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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