FDA 510(k) Application Details - K153605

Device Classification Name	More FDA Info for this Device
510(K) Number	K153605
Device Name	ivWatch Model 400
Applicant	ivWatch, LLC 469 McLaws Circle Williamsburg, VA 23185 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	12/17/2015
Decision Date	02/11/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review