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

    PATIENT RESTRAINT

    K Number: K971948 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    133
    Applicant Total
    2
    Review Days
    70

    Basic Information

    Device Name
    PATIENT RESTRAINT
    K Number
    K971948
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E.M. ADAMS CO., INC.
    Date Received
    May 28, 1997
    Decision Date
    August 6, 1997
    Product Code
    FMQ
    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
    FMQ Restraint, Protective

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    Other Clearances by E.M. ADAMS CO., INC.

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