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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 body temperature sensing software
De Novo Number DEN230050
Device Name Body Temperature Software (BTS)
Requester
fitbit llc
199 fremont street, 14th floor
san francisco,  CA  94105
Contact nathan austin
Regulation Number880.2915
Classification Product Code
QZA  
Date Received07/17/2023
Decision Date 12/15/2023
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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