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

    CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM

    K Number: K943097 · Decision Dec 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    1
    Review Days
    178

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    Basic Information

    Device Name
    CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM
    K Number
    K943097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5550
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Global Medical Technologies, Inc.
    Date Received
    June 28, 1994
    Decision Date
    December 23, 1994
    Product Code
    FNM
    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
    FNM Mattress, Air Flotation, Alternating Pressure

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