FDA 510(k) Application Details - K010482

Device Classification Name	Transducer, Ultrasonic   More FDA Info for this Device
510(K) Number	K010482
Device Name	Transducer, Ultrasonic
Applicant	ECHOCATH, INC. 4326 U.S. ROUTE #1 MONMOUTH JUNCTION, NJ 08852 US Other 510(k) Applications for this Company
Contact	DAVID LYONS 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	02/20/2001
Decision Date	03/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review