FDA 510(k) Application Details - K172716

Device Classification Name	More FDA Info for this Device
510(K) Number	K172716
Device Name	V2K Rinspiration System
Applicant	V2K Medical Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Jake Wolenberg Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2017
Decision Date	01/26/2018
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