FDA 510(k) Application Details - K242967

Device Classification Name	More FDA Info for this Device
510(K) Number	K242967
Device Name	Loss of Pulse Detection
Applicant	Fitbit 215 Fremont Street San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Dinesh Puppala Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	02/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review