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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 temperature regulation device for esophageal protection during cardiac ablation
De Novo Number DEN230021
Device Name ensoETM
Requester
advanced cooling therapy, inc. d/b/a attune medical
3440 s. dearborn st.
#215-south
chicago,  IL  60616
Contact erik kulstad
Regulation Number870.5720
Classification Product Code
QXV  
Date Received03/30/2023
Decision Date 09/13/2023
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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