Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K201370 |
Device Name |
Multiflex Tinnitus Technology |
Applicant |
Starkey Laboratories, Inc. |
6700 Washington Ave S |
Eden Prairie,
MN
55344
|
|
Applicant Contact |
Ka Zoua Xiong |
Correspondent |
Starkey Laboratories, Inc. |
6700 Washington Ave S |
Eden Prairie,
MN
55344
|
|
Correspondent Contact |
Ka Zoua Xiong |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 05/22/2020 |
Decision Date | 06/19/2020 |
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
|
|
|