FDA 510(k) Application Details - K961002

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K961002
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	DIASONICS ULTRASOUND 2860 DELA CRUZ BLVD. SANTA CLARA, CA 95050 US Other 510(k) Applications for this Company
Contact	JERRY W TSUTSUMI 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	03/12/1996
Decision Date	01/22/1997
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