• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name densitometer, bone
510(k) Number K121716
Model TBS INSIGHT
Device Name TBS INSIGHT
Original Applicant
MEDIMAPS GROUP SA
18 chemin des aulx
plan les ouates,  SZ 1228
Original Contact christophe lelong
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/11/2012
Decision Date 10/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-