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

    POWERED LOW AIR LOSS MATTRESS SYSTEM

    K Number: K961159 · Decision Jun 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    19
    Review Days
    84

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    Basic Information

    Device Name
    POWERED LOW AIR LOSS MATTRESS SYSTEM
    K Number
    K961159
    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
    March 22, 1996
    Decision Date
    June 14, 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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    K953503 PRESSUREGUARD IV
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