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

    PRESSURE SENTRY TOURNIQUET

    K Number: K840206 · Decision Apr 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    33
    Applicant Total
    71
    Review Days
    97

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    Basic Information

    Device Name
    PRESSURE SENTRY TOURNIQUET
    K Number
    K840206
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    January 19, 1984
    Decision Date
    April 25, 1984
    Product Code
    KCY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCY Tourniquet, Pneumatic

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