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

    COMPONENT NEUROMONITORING SYSTEM

    K Number: K080217 · Decision Nov 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    281

    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
    COMPONENT NEUROMONITORING SYSTEM
    K Number
    K080217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moberg Research, Inc.
    Date Received
    January 29, 2008
    Decision Date
    November 5, 2008
    Product Code
    OMA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    OMA Amplitude-Integrated Electroencephalograph

    Similar 510(k) Clearances

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

    Neo

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nihon Kohden QP-160AK EEG Trend Program

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cadwell AmpliScan

    FDA 510(k)
    FDA Class 2 ·Neurology

    Background Pattern Classification [BPc(TM)]

    FDA 510(k)
    FDA Class 2 ·Neurology

    NIHON KOHDEN AE-918P NEURO UNIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CEREBRALOGIK- AEEG

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

    Other Clearances by Moberg Research, Inc.

    K Number Device Name
    K192572 CNS Envision