BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Apollo TMS Therapy System

    K Number: K180313 · Decision May 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    5
    Review Days
    88

    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
    Apollo TMS Therapy System
    K Number
    K180313
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mag & More GmbH
    Date Received
    February 5, 2018
    Decision Date
    May 4, 2018
    Product Code
    OBP
    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
    OBP Transcranial Magnetic Stimulator

    Similar 510(k) Clearances

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

    MagVenture Accelerated TMS (aTMS) Therapy System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Apollo TMS Therapy System;Apollo light TMS Therapy System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPRY TMS Therapy System (0550)

    FDA 510(k)
    FDA Class 2 ·Neurology

    BrainsWay Deep TMS System

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

    Other Clearances by Mag & More GmbH

    K Number Device Name
    K260560 Apollo TMS Therapy System;Apollo light TMS Therapy System
    K243700 Apollo TMS Therapy System
    K243539 Apollo TMS Therapy System
    K232639 Apollo TMS Therapy System