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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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De Novo Number DEN250044
Device Name STEMI AI ECG Model
Requester
powerful medical, inc.
7th floor, 33 w. 17th st.
new york,  CA  10011
Contact arezou azar
Classification Product Code
SHS
Date Received09/22/2025
Decision Date 09/03/2026
Decision granted (DENG)
Review Advisory Committee Cardiovascular
Type Direct
Predetermined Change
Control Plan Authorized		 Yes
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