FDA 510(k) Application Details - K161700

Device Classification Name	More FDA Info for this Device
510(K) Number	K161700
Device Name	SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
Applicant	STERILMED, INC. 5010 CHESHIRE PARKWAY STE. 2 Plymouth, MN 55446 US Other 510(k) Applications for this Company
Contact	Reuben Lawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2016
Decision Date	11/21/2016
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