FDA 510(k) Application Details - K153762

Device Classification Name	Transducer, Ultrasonic   More FDA Info for this Device
510(K) Number	K153762
Device Name	Transducer, Ultrasonic
Applicant	KOVEN TECHNOLOGY, INC. 12125 WOODCREST EXECUTIVE DR SUITE 320 ST LOUIS, MO 63141 US Other 510(k) Applications for this Company
Contact	Heather Bell Other 510(k) Applications for this Contact
Regulation Number	870.2880   More FDA Info for this Regulation Number
Classification Product Code	JOP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2015
Decision Date	05/25/2016
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