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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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Device Classification Name ultrasound imaging system for acquiring images at home by lay users
De Novo Number DEN240074
Device Name Pulsenmore ES
Requester
pulsenmore ltd.
8 omarim st.
omer,  IL 8496500
Contact israel citron
Regulation Number892.1590
Classification Product Code
SGJ  
Date Received12/11/2024
Decision Date 10/31/2025
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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