FDA 510(k) Application Details - K982345

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K982345
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	CARDIAC MARINERS, INC. 120-B ALBRIGHT WAY LOS GATOS, CA 95030 US Other 510(k) Applications for this Company
Contact	E. BRUCE FLOYD Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/1998
Decision Date	09/01/1998
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