FDA 510(k) Application Details - K023178

Device Classification Name	More FDA Info for this Device
510(K) Number	K023178
Device Name	INNOVA 4100
Applicant	GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	LARRY A KROGER, PH.D 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	09/23/2002
Decision Date	11/26/2002
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