FDA 510(k) Application Details - K211691

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K211691
Device Name	Media,Coupling,Ultrasound
Applicant	Ultrast, Inc. 3286 Balsam St Oceanside, NY 11572 US Other 510(k) Applications for this Company
Contact	Howard Levine Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2021
Decision Date	12/22/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review