FDA 510(k) Application Details - K243778

Device Classification Name	More FDA Info for this Device
510(K) Number	K243778
Device Name	Body Temperature Software (BTS)
Applicant	Fitbit LLC 215 Fremont St 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	12/09/2024
Decision Date	02/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review