FDA 510(k) Application Details - K232548

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K232548
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Corsano Health B.V. Wilhelmina Van Pruisenweg 35 's-Gravenhage 2595 AN NL Other 510(k) Applications for this Company
Contact	Peter Stas 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	08/23/2023
Decision Date	03/22/2024
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