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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 guided nerve block assist
De Novo Number DEN220024
Device Name ScanNav Anatomy Peripheral Nerve Block
Requester
intelligent ultrasound limited
floor 6a, hodge house, 114-116 st. mary st.
cardiff,  GB cf10 1dy
Contact nicholas sleep
Regulation Number868.1980
Classification Product Code
QRG  
Date Received04/08/2022
Decision Date 10/18/2022
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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