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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name hearing aid, bone conduction, implanted
510(K) Number K121228
Device Name PONTO BONE ANCHORED HEARING SYSTEM
Applicant
OTICON MEDICAL AB
ekonomivagen 2
askim, 
Contact karolin isberg jernby
Regulation Number874.3300
Classification Product Code
MAH  
Date Received05/17/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-