FDA 510(k) Application Details - K192211

Device Classification Name	More FDA Info for this Device
510(K) Number	K192211
Device Name	SoundBite Console, SoundBite Active Wire 18
Applicant	SoundBite Medical Solution Inc. 2300 Blvd Alfred Nobel Montreal h4S 2A4 CA Other 510(k) Applications for this Company
Contact	Marc Andre Cote 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	08/14/2019
Decision Date	01/17/2020
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