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FDA Product Code

FDA Product Code QQC — Clearance Directory

Device Class
Class II
Assigned Panel
Neurology
21 CFR Citation
882.5855

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K243520 Bullsai Confirm Turing Medical Technologies, Inc. 2025-03-28 Traditional PDF ↗
K213930 Brainlab Elements Guide XT, Guide 3.0 Brainlab AG 2022-04-19 Traditional PDF ↗
DEN210003 SureTune4 Software Medtronic Neuromodulation 2021-08-23 Direct —

Product code QQC · Class II · Neurology. Data: openFDA.