FDA 510(k) Application Details - K982568

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K982568
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	GERALD MCMORROW 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	07/23/1998
Decision Date	01/25/1999
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