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

    MAXI-FLOW

    K Number: K955150 · Decision Jan 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    MAXI-FLOW
    K Number
    K955150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Medical Devices, Inc.
    Date Received
    November 13, 1995
    Decision Date
    January 23, 1996
    Product Code
    BYY
    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
    BYY Tube, Aspirating, Flexible, Connecting

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BYY), ordered by most recent decision date.

    VITAFLOW SUCTION/ASPIRATION TUBING SET

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    CONNECTING TUBING

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    MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL

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    FDA Class 2 ·General Hospital

    MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR

    FDA 510(k)
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    WILTEK IRRIGAITON/ASPIRATION TUBE SET

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    FDA Class 2 ·General Hospital

    GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)

    FDA 510(k)
    FDA Class 2 ·General Hospital
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    Other Clearances by Bio-Medical Devices, Inc.

    K Number Device Name
    K040485 MAXAIR SURGICAL HELMET SYSTEM
    K981888 SMOKE-EVAC
    K955149 MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
    K955151 MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
    K940156 THE REEL THING
    K933742 TOP GUN