FDA 510(k) Application Details - K090268

Device Classification Name System, X-Ray, Mobile

  More FDA Info for this Device
510(K) Number K090268
Device Name System, X-Ray, Mobile
Applicant SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
Other 510(k) Applications for this Company
Contact DON KARLE
Other 510(k) Applications for this Contact
Regulation Number 892.1720

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

  More FDA Info for this Product Code
Date Received 02/03/2009
Decision Date 06/30/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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