FDA 510(k) Application Details - K220956

Device Classification Name	More FDA Info for this Device
510(K) Number	K220956
Device Name	Libby Echo:Prio
Applicant	Dyad Medical, Inc 215 Brighton Avenue, Suite 203 Boston, MA 02134 US Other 510(k) Applications for this Company
Contact	Ronny Shalev Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2022
Decision Date	07/20/2022
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