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

    ALTERNATING PRESSURE AIR FLOTATION MATTRESS

    K Number: K972153 · Decision Jul 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    1
    Review Days
    52

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ALTERNATING PRESSURE AIR FLOTATION MATTRESS
    K Number
    K972153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5550
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Decubiti Concepts, Inc.
    Date Received
    June 9, 1997
    Decision Date
    July 31, 1997
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.

    PRESSURE GUARD SITE SELECT (A)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MIGHTY AIR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZAK-2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHYSIO/1000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIMPULSE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all