FDA 510(k) Application Details - K211513

Device Classification Name	More FDA Info for this Device
510(K) Number	K211513
Device Name	sam X1 Long Duration Ultrasound Device
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	05/14/2021
Decision Date	08/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review