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FDA Product Code

FDA Product Code SFN — Clearance Directory

Device Class
Class II
Assigned Panel
Neurology
21 CFR Citation
882.1860

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN250002 Delphi-MD System Quantalx Neuroscience, Ltd. 2025-08-20 Direct —

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