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FDA Product Code

FDA Product Code QAF — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.2770

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K253840 STEDI Scan Device Stroke DX 2026-07-22 Traditional PDF ↗
K182967 Visor System Cerebrotech Medical Systems, Inc. 2018-11-23 Special PDF ↗
K171186 Cerebrotech CMS-5000 Cerebrotech Medical Systems 2017-12-08 Traditional PDF ↗

Product code QAF · Class II · Cardiovascular. Data: openFDA.