FDA 510(k) Application Details - K171029

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K171029
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	Visicu Inc. 217 East Redwood St. Suite 1900 Baltimore, MD 21202 US Other 510(k) Applications for this Company
Contact	Daniel R. Plonski Other 510(k) Applications for this Contact
Regulation Number	870.2910   More FDA Info for this Regulation Number
Classification Product Code	DRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2017
Decision Date	07/14/2017
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