• 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 hearing aid, bone conduction, implanted
510(k) Number K121228
Device Name PONTO BONE ANCHORED HEARING SYSTEM
Original Applicant
OTICON MEDICAL AB
ekonomivagen 2
askim,  SW se-436 33
Original 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
-
-