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FDA Product Code

FDA Product Code SHO — Clearance Directory

Device Class
Class II
Assigned Panel
Neurology
21 CFR Citation
882.2000

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN240071 neuropacs Automated Imaging Diagnostics, LLC 2026-04-03 Direct —

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