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FDA Product Code

FDA Product Code SHS — Clearance Directory

Device Class
—
Assigned Panel
Unknown

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
DEN250044 Queen of Hearts (ACS AI ECG Model) Powerful Medical, Inc. 2026-09-03 Direct —

Product code SHS · · Unknown. Data: openFDA.