FDA 510(k) Application Details - K072665

Device Classification Name System, Image Processing, Radiological

  More FDA Info for this Device
510(K) Number K072665
Device Name System, Image Processing, Radiological
Applicant ORANGEDENTAL GMBH & CO. KG
IM FORSTGARTEN 11
BIBERACH 88400 DE
Other 510(k) Applications for this Company
Contact MARC FIEBER
Other 510(k) Applications for this Contact
Regulation Number 892.2050

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

  More FDA Info for this Product Code
Date Received 09/21/2007
Decision Date 10/03/2007
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 Y
Expedited Review



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