FDA 510(k) Application Details - K182637

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K182637
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen 71034 DE Other 510(k) Applications for this Company
Contact	Michael Asmalsky 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	09/24/2018
Decision Date	04/26/2019
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