Device Classification Name |
hearing aid, bone conduction, implanted
|
510(k) Number |
K203807 |
Device Name |
Ponto Bone Anchored Hearing System, MONO Surgery Kit |
Applicant |
Oticon Medical AB |
Datavagen 37B |
Askim,
SE
SE-436 32
|
|
Applicant Contact |
Carolina Anker Wessling |
Correspondent |
Oticon Medical AB |
Datavagen 37B |
Askim,
SE
SE-436 32
|
|
Correspondent Contact |
Carolina Anker Wessling |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 12/28/2020 |
Decision Date | 03/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|