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

    Zmachine Synergy

    K Number: K172986 · Decision Dec 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    83

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    Basic Information

    Device Name
    Zmachine Synergy
    K Number
    K172986
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Research of Richmond, Inc. Dba General Sleep CO
    Date Received
    September 27, 2017
    Decision Date
    December 19, 2017
    Product Code
    OLV
    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
    OLV Standard Polysomnograph With Electroencephalograph

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