FDA 510(k) Application Details - K973598

Device Classification Name	More FDA Info for this Device
510(K) Number	K973598
Device Name	SIREMOBIL CO2
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH ISELIN, NJ 08830 US Other 510(k) Applications for this Company
Contact	KATHLEEN RUTHERFORD Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/1997
Decision Date	11/10/1997
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