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

    TALLEY SD.500 SKIN PRESSURE EVALUATOR

    K Number: K914780 · Decision Dec 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    57

    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
    TALLEY SD.500 SKIN PRESSURE EVALUATOR
    K Number
    K914780
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Talley Group, Ltd.
    Date Received
    October 23, 1991
    Decision Date
    December 19, 1991
    Product Code
    IKE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IKE Transducer, Miniature Pressure

    Similar 510(k) Clearances

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

    SONIC PALPOMETER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PRESSORE MONITOR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    THE EQUALIZER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PORTABLE LIMB LOAD MONITOR (BMLLM-100)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    IOWA ORAL PERFORMANCE ISNTRUMENT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FPL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Talley Group, Ltd.

    K Number Device Name
    K151263 Venturi Gauze Wound Care Sets with Portal Drain
    K143004 VENTURI MiNO TG600/14
    K914775 TALLEY MICRO SYSTEM/TALLEY RIPPLEBED
    K914774 MULTIPULSE SEQUENTIAL COMPRESSION UNIT
    K914776 OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR