Cleared Traditional

MagVenture TMS Atlas Neuro Navigation System

K221544 · Tonica Elektronik A/S · Neurology
Mar 2023
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K221544 is an FDA 510(k) clearance for the MagVenture TMS Atlas Neuro Navigation System, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on March 17, 2023, 294 days after receiving the submission on May 27, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K221544 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2022
Decision Date March 17, 2023
Days to Decision 294 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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