FDA 510(k) Application Details - K222212

Device Classification Name	More FDA Info for this Device
510(K) Number	K222212
Device Name	ivWatch Model 400
Applicant	ivWatch, LLC 700 Tech Center Parkway, 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	07/25/2022
Decision Date	08/24/2022
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