FDA 510(k) Application Details - K021049

Device Classification Name	More FDA Info for this Device
510(K) Number	K021049
Device Name	OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
Applicant	GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	BILL GISLASON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2002
Decision Date	04/17/2002
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