FDA 510(k) Application Details - K984639

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K984639
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	MEDISON AMERICA, INC. 6616 OWENS DR. PLEASANTON, CA 94588 US Other 510(k) Applications for this Company
Contact	BOB LEIKER 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	12/31/1998
Decision Date	07/12/1999
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