FDA 510(k) Application Details - K192385

Device Classification Name	More FDA Info for this Device
510(K) Number	K192385
Device Name	ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
Applicant	ivWatch, LLC 630 Hofstadter Road, Suite 300 Newport News, VA 23606 US Other 510(k) Applications for this Company
Contact	Holly Novak 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	09/03/2019
Decision Date	07/02/2020
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