FDA 510(k) Application Details - K233418

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K233418
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Biofourmis Singapore Pte. Ltd. 2 Venture Drive, Vision Exchange, #23-01 Singapore 608526 SG Other 510(k) Applications for this Company
Contact	Seth Kuzdzal Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2023
Decision Date	05/09/2024
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