FDA 510(k) Application Details - DEN230050

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230050
Device Name	Body Temperature Software (BTS)
Applicant	Fitbit LLC 199 Fremont Street, 14th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Nathan Austin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2023
Decision Date	12/15/2023
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review