Cleared Traditional

Cranial EM System

K213989 · Brainlab AG · Neurology
Sep 2022
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K213989 is an FDA 510(k) clearance for the Cranial EM System, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on September 8, 2022, 262 days after receiving the submission on December 20, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K213989 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2021
Decision Date September 08, 2022
Days to Decision 262 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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