FDA 510(k) Application Details - K230159

Device Classification Name	More FDA Info for this Device
510(K) Number	K230159
Device Name	SoundBite« Crossing System XS Peripheral
Applicant	Soundbite Medical Solutions, Inc. 2300 Alfred Nobel, Suite 230 Montreal H4S 2A4 CA Other 510(k) Applications for this Company
Contact	Diane Marceau Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2023
Decision Date	08/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review