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

    MAXAIR SURGICAL HELMET SYSTEM

    K Number: K040485 · Decision Oct 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    7
    Review Days
    236

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    Basic Information

    Device Name
    MAXAIR SURGICAL HELMET SYSTEM
    K Number
    K040485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Medical Devices, Inc.
    Date Received
    February 25, 2004
    Decision Date
    October 18, 2004
    Product Code
    FYA
    Advisory Committee
    General, Plastic Surgery
    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
    FYA Gown, Surgical

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    Other Clearances by Bio-Medical Devices, Inc.

    K Number Device Name
    K981888 SMOKE-EVAC
    K955149 MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
    K955151 MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
    K955150 MAXI-FLOW
    K940156 THE REEL THING
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