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

    PENOX HOSPITAL BED

    K Number: K864667 · Decision Jan 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    221
    Registration Numbers
    221
    Same Product Code
    38
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    PENOX HOSPITAL BED
    K Number
    K864667
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5120
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Penox Technologies, Inc.
    Date Received
    December 2, 1986
    Decision Date
    January 21, 1987
    Product Code
    FNJ
    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
    FNJ Bed, Manual

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    K851217 PENOX DUAL FLOW MINIFOLD
    K851216 PENOX DUAL FEED MANIFOLD
    K851215 T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER
    K851219 FILL HOSE SAFETY ADAPTER