Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, x-ray, extraoral source, digital
510(k) Number K161131
Device Name FONA Pan/Ceph
Applicant
FONA SRL
VIA GALILEO GALILEI 11
ASSAGO,  IT 20090
Applicant Contact ELISA GUSBERTI
Correspondent
FONA SRL
VIA GALILEO GALILEI 11
ASSAGO,  IT 20090
Correspondent Contact ELISA GUSBERTI
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/21/2016
Decision Date 11/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-