FDA 510(k) Application Details - K953819

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K953819
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	BIOSOUND, INC. 7990 CASTLEWAY DR. P.O. BOX 50867 INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	WAUNY NETHERCUTT 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	08/15/1995
Decision Date	03/01/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review