FDA 510(k) Application Details - K960266

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

  More FDA Info for this Device
510(K) Number K960266
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN, NJ 08830 US
Other 510(k) Applications for this Company
Contact KATHY RUTHERFORD
Other 510(k) Applications for this Contact
Regulation Number 892.1650

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

  More FDA Info for this Product Code
Date Received 01/18/1996
Decision Date 03/11/1996
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