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

    HOMEVUE WOUND MONITORING SYSTEM

    K Number: K945807 · Decision Aug 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    2
    Review Days
    252

    Basic Information

    Device Name
    HOMEVUE WOUND MONITORING SYSTEM
    K Number
    K945807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    HOMEVUE HEALTH SYSTEMS, INC.
    Date Received
    November 28, 1994
    Decision Date
    August 7, 1995
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by HOMEVUE HEALTH SYSTEMS, INC.

    K Number Device Name
    K912138 HOMEVUE MONITORING SYS.MODEL TD 2000