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

    Apollo TMS Therapy System

    K Number: K243539 · Decision Aug 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    5
    Review Days
    276

    Basic Information

    Device Name
    Apollo TMS Therapy System
    K Number
    K243539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mag & More GmbH
    Date Received
    November 15, 2024
    Decision Date
    August 18, 2025
    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

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    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
    K232639 Apollo TMS Therapy System
    K180313 Apollo TMS Therapy System