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

    5000Z SYSTEM (OTC)

    K Number: K033122 · Decision Aug 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    8
    Review Days
    330

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    Basic Information

    Device Name
    5000Z SYSTEM (OTC)
    K Number
    K033122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Prizm Medical, Inc.
    Date Received
    September 30, 2003
    Decision Date
    August 25, 2004
    Product Code
    NUH
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    K951727 Z-WATCH SYSTEM
    K944487 ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES
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