Device Classification Name |
hearing aid, bone conduction
|
510(k) Number |
K161671 |
Device Name |
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower |
Applicant |
OTICON MEDICAL AB |
DATAVAGEN 37B |
ASKIM,
SE
SE-436 32
|
|
Applicant Contact |
Satu Hjartstam |
Correspondent |
OTICON MEDICAL AB |
DATAVAGEN 37B |
ASKIM,
SE
SE-436 32
|
|
Correspondent Contact |
Satu Hjartstam |
Regulation Number | 874.3302
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/16/2016 |
Decision Date | 09/29/2016 |
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
|
|
|