Device Classification Name |
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
|
510(k) Number |
K211380 |
Device Name |
Elexir |
Applicant |
Nu Eyne Co., Ltd. |
#608, 28, Digital-ro 30-gil, Guro-gu |
Seoul,
KR
08389
|
|
Applicant Contact |
Dong Seong Lee |
Correspondent |
Nu Eyne Co., Ltd. |
#608, 28, Digital-ro 30-gil, Guro-gu |
Seoul,
KR
08389
|
|
Correspondent Contact |
Dong Seong Lee |
Regulation Number | 882.5891
|
Classification Product Code |
|
Date Received | 05/04/2021 |
Decision Date | 07/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|