FDA 510(k) Application Details - K982208

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K982208
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	JOMED IMAGING LTD. 3A CENTAURS BUSINESS PARK GRANT WAY ISLEWORTH MIDDLESEX TW 7 5QD GB Other 510(k) Applications for this Company
Contact	CAROLINE SHORT 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	06/23/1998
Decision Date	08/27/1999
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