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

    THE BAGNOLI-2 EMG SYSTEM

    K Number: K945286 · Decision Sep 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    3
    Review Days
    319

    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
    THE BAGNOLI-2 EMG SYSTEM
    K Number
    K945286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Delsys, Inc.
    Date Received
    October 31, 1994
    Decision Date
    September 15, 1995
    Product Code
    HCC
    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
    HCC Device, Biofeedback

    Similar 510(k) Clearances

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

    A Breathing System (ABS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Prism

    FDA 510(k)
    FDA Class 2 ·Neurology

    Freespira

    FDA 510(k)
    FDA Class 2 ·Neurology

    GrindCare System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Pacifier Activated Lullaby (PAL®)

    FDA 510(k)
    FDA Class 2 ·Neurology

    NFANT Feeding Solution

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

    Other Clearances by Delsys, Inc.

    K Number Device Name
    K990356 THE BAGNOLI-8 EMG SYSTEM
    K981934 THE BAGNOLI-4 EMG SYSTEM