FDA 510(k) Application Details - K191568

Device Classification Name	More FDA Info for this Device
510(K) Number	K191568
Device Name	sam 2.0 Long Duration Ultrasound System
Applicant	ZetrOZ Systems, LLC 56 Quarry Road Trumbull, CT 06611 US Other 510(k) Applications for this Company
Contact	Sabrina Lewis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2019
Decision Date	03/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review