FDA 510(k) Application Details - K190591

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K190591
Device Name	Media,Coupling,Ultrasound
Applicant	Safersonic US, Inc. 2873 Arlington AV, Ste. 110 Highland Park, IL 60035 US Other 510(k) Applications for this Company
Contact	David L. Seitelman 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	03/07/2019
Decision Date	10/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review