FDA 510(k) Application Details - K010942

Device Classification Name	More FDA Info for this Device
510(K) Number	K010942
Device Name	U04
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH ISELIN, NJ 08830 US Other 510(k) Applications for this Company
Contact	AMY SHAW HOSLER 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	03/29/2001
Decision Date	04/12/2001
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	Y
Expedited Review