FDA 510(k) Application Details - K211046

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K211046
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Visicu, Inc. 217 East Redwood Street Baltimore, MD 21202 US Other 510(k) Applications for this Company
Contact	Janine Treter 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	04/08/2021
Decision Date	06/03/2022
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