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,
SE
SE-436 33
|
|
Applicant Contact |
KAROLIN ISBERG JERNBY |
Correspondent |
OTICON MEDICAL AB |
EKONOMIVAGEN 2 |
ASKIM,
SE
SE-436 33
|
|
Correspondent Contact |
KAROLIN ISBERG JERNBY |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 04/23/2012 |
Decision Date | 09/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|