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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 brain temperature measurement system
De Novo Number DEN200042
Device Name BrainTemp Neonate System (BTNeo System)
Requester
brain temp, inc.
p.o. box 823
bryn mawr,  PA  19010
Contact david anderson
Regulation Number882.1565
Classification Product Code
QSL  
Date Received06/23/2020
Decision Date 03/29/2022
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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