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

    MODEL 7-AT TREATMENT CHAMBER

    K Number: K896721 · Decision Jan 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    25
    Review Days
    55

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    Basic Information

    Device Name
    MODEL 7-AT TREATMENT CHAMBER
    K Number
    K896721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    J. H. Emerson Co.
    Date Received
    November 28, 1989
    Decision Date
    January 22, 1990
    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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