FDA 510(k) Application Details - K243146

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K243146
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	iHealth Labs, Inc. 880 W Maude Ave Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Tianyang Liu Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	02/03/2025
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