FDA 510(k) Application Details - K983691

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K983691
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	SONOTECH, INC. P.O. BOX 10489 STATE COLLEGE, PA 16805 US Other 510(k) Applications for this Company
Contact	MARGARET J LARSON Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/1998
Decision Date	05/05/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review