BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    NExT Station; NExT Station Advanced

    K Number: K242832 · Decision Dec 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    13
    Review Days
    84

    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
    NExT Station; NExT Station Advanced
    K Number
    K242832
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eb Neuro S.P.A.
    Date Received
    September 19, 2024
    Decision Date
    December 12, 2024
    Product Code
    GWL
    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
    GWL Amplifier, Physiological Signal

    Similar 510(k) Clearances

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

    Delphi Amplifier

    FDA 510(k)
    FDA Class 2 ·Neurology

    DreamClear

    FDA 510(k)
    FDA Class 2 ·Neurology

    BE Plus PRO, Neurotravel LIGHT

    FDA 510(k)
    FDA Class 2 ·Neurology

    X-trodes System M

    FDA 510(k)
    FDA Class 2 ·Neurology

    Vlab

    FDA 510(k)
    FDA Class 2 ·Neurology

    SomniCheck

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

    Other Clearances by Eb Neuro S.P.A.

    K Number Device Name
    K242305 BE Plus PRO, Neurotravel LIGHT
    K150220 STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
    K142064 GALILEO NT
    K133517 NEMUS 2 SYSTEM
    K121996 BE PLUS LTM AMPLIFIER GWI AMPLIFIER
    K093728 BE MICRO, TREA
    K073415 NEMUS SYSTEM; NEMUS PC PERIPHERAL
    K061996 SANDMAN POCKET
    K053606 BE PLUS / AURA-LTM64 AMPLIFIER
    K041198 NIC36 AMPLIFIER
    Search all 13 clearances from Eb Neuro S.P.A. →