FDA 510(k) Application Details - K103489

Device Classification Name System, X-Ray, Tomography, Computed

  More FDA Info for this Device
510(K) Number K103489
Device Name System, X-Ray, Tomography, Computed
Applicant GENERAL ELECTRIC CO.
3000 N. GRANDVIEW BLVD.
W1140
WAUKESHA, WI 53188 US
Other 510(k) Applications for this Company
Contact ANDREW J MENDEN
Other 510(k) Applications for this Contact
Regulation Number 892.1750

  More FDA Info for this Regulation Number
Classification Product Code JAK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/26/2010
Decision Date 09/09/2011
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