BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    ELEXOMA MEDIC

    K Number: K070412 · Decision May 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    464

    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
    ELEXOMA MEDIC
    K Number
    K070412
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Redplane AG
    Date Received
    February 12, 2007
    Decision Date
    May 21, 2008
    Product Code
    QJQ
    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
    QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

    Similar 510(k) Clearances

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

    Genesis Sleep

    FDA 510(k)
    FDA Class 2 ·Neurology

    Modius Stress

    FDA 510(k)
    FDA Class 2 ·Neurology

    Modius Sleep

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cervella

    FDA 510(k)
    FDA Class 2 ·Neurology

    CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C

    FDA 510(k)
    FDA Class 2 ·Neurology

    CES ULTRA

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all