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

    I.V. BOTTLE (RIDGID)

    K Number: K811234 · Decision Jun 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    12
    Review Days
    45

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    Basic Information

    Device Name
    I.V. BOTTLE (RIDGID)
    K Number
    K811234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medi-Plast Intl., Inc.
    Date Received
    May 4, 1981
    Decision Date
    June 18, 1981
    Product Code
    KPE
    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
    KPE Container, I.V.

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    Other Clearances by Medi-Plast Intl., Inc.

    K Number Device Name
    K954284 MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
    K873588 10CC CONTROL SYRINGE
    K863402 MEDI-PLAST DISPOSABLE MANIFOLD
    K861785 FLUOROSCOPE BAND BAG
    K851489 ARTERIAL-VENOUS COMPRESSION DRESSING
    K842136 STERILE PAN SET
    K840021 OPERATING ROOM TRAY SET
    K840022 HEART CATHETERIZATION TRAY SET
    K811268 BOTTLE-TO-BOTTLE
    K811233 I.V. PLASTIC BAG
    Search all 12 clearances from Medi-Plast Intl., Inc. →