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

    PRESSURE GUARD ALTERNATING PRESSURE MATTRESS

    K Number: K954766 · Decision Jan 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    19
    Review Days
    86

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    Basic Information

    Device Name
    PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
    K Number
    K954766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5550
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Span-America Medical Systems, Inc.
    Date Received
    October 17, 1995
    Decision Date
    January 11, 1996
    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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    K961159 POWERED LOW AIR LOSS MATTRESS SYSTEM
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    K951112 PRESSUREGUARD IV
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