Device Classification Name |
Masker, Tinnitus
|
510(k) Number |
K151719 |
Device Name |
REVE134 |
Applicant |
KW EAR LAB, INC |
18655 South Bishop Ave |
Carson,
CA
90746
|
|
Applicant Contact |
Sungwoo Cho |
Correspondent |
KW EAR LAB, INC |
18655 South Bishop Ave |
Carson,
CA
90746
|
|
Correspondent Contact |
Sungwoo Cho |
Regulation Number | 874.3400
|
Classification Product Code |
|
Date Received | 06/25/2015 |
Decision Date | 10/09/2015 |
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
|
|
|