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

    MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM

    K Number: K912444 · Decision Feb 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    50
    Review Days
    260

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    Basic Information

    Device Name
    MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
    K Number
    K912444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Radiometer America, Inc.
    Date Received
    June 3, 1991
    Decision Date
    February 18, 1992
    Product Code
    LGM
    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
    LGM Chamber, Patient Isolation

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