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

    DECOMAT A 8666

    K Number: K920413 · Decision Apr 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    795

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    Basic Information

    Device Name
    DECOMAT A 8666
    K Number
    K920413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6992
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Getinge International, Inc.
    Date Received
    January 31, 1992
    Decision Date
    April 5, 1994
    Product Code
    MDZ
    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
    MDZ Cleaners, Medical Devices

    Similar 510(k) Clearances

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

    DECOMAT 228

    FDA 510(k)
    FDA Class 2 ·General Hospital
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