FDA 510(k) Application Details - K121716

Device Classification Name Densitometer, Bone

  More FDA Info for this Device
510(K) Number K121716
Device Name Densitometer, Bone
Applicant MEDIMAPS GROUP SA
18 CHEMIN DES AULX
PLAN LES OUATES 1228 CH
Other 510(k) Applications for this Company
Contact CHRISTOPHE LELONG
Other 510(k) Applications for this Contact
Regulation Number 892.1170

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

  More FDA Info for this Product Code
Date Received 06/11/2012
Decision Date 10/05/2012
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