FDA 510(k) Application Details - K003266

Device Classification Name

  More FDA Info for this Device
510(K) Number K003266
Device Name SIREMOBIL ISO-C 3D
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 OXO
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/18/2000
Decision Date 12/01/2000
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact