FDA 510(k) Application Details - K162478

Device Classification Name	More FDA Info for this Device
510(K) Number	K162478
Device Name	ivWatch
Applicant	ivWatch, LLC 1100 Exploration Way, Suite 209 Hampton, VA 23666 US Other 510(k) Applications for this Company
Contact	Jaclyn Lautz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2016
Decision Date	12/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review