BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOFT-COVER

    K Number: K921928 · Decision Nov 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    210
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    196

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    Basic Information

    Device Name
    SOFT-COVER
    K Number
    K921928
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6190
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Adroit Medical Systems, Inc.
    Date Received
    April 24, 1992
    Decision Date
    November 6, 1992
    Product Code
    FMW
    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
    FMW Cover, Mattress (Medical Purposes)

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