BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Vlab

    K Number: K230148 · Decision Oct 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    265

    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
    Vlab
    K Number
    K230148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dormotech Medical, Ltd.
    Date Received
    January 19, 2023
    Decision Date
    October 11, 2023
    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

    NExT Station; NExT Station Advanced

    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

    SomniCheck

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

    Other Clearances by Dormotech Medical, Ltd.

    K Number Device Name
    K242290 DormoTech NLab