FDA 510(k) Application Details - K242750

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K242750
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Nihon Kohden Digital Health Solutions, LLC 14 Bunsen Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Arthur Webb 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	09/12/2024
Decision Date	06/05/2025
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