Cleared Abbreviated

Apollo TMS Therapy System

K180313 · Mag & More GmbH · Neurology
May 2018
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K180313 is an FDA 510(k) clearance for the Apollo TMS Therapy System, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Mag & More GmbH (Munich, DE). The FDA issued a Cleared decision on May 4, 2018, 88 days after receiving the submission on February 5, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K180313 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2018
Decision Date May 04, 2018
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.