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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 adjunctive pain measurement device for anesthesiology
De Novo Number DEN210022
Device Name PMD-200
Requester
medasense biometrics , ltd.
4 hachilazon st.
ramat gan,  IL 5252268
Contact rachel weissbrod
Regulation Number868.2200
Classification Product Code
QVE  
Date Received06/04/2021
Decision Date 02/17/2023
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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