Device Classification Name |
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
|
510(k) Number |
K160237 |
FOIA Releasable 510(k) |
K160237
|
Device Name |
Cefaly |
Applicant |
CEFALY TECHNOLOGY |
ZI DES HAUTS SARTS, 4EME AVENUE 5 |
HERSTAL,
BE
4040
|
|
Applicant Contact |
JEAN-YVES MIGNOLET |
Correspondent |
CEFALY TECHNOLOGY |
ZI DES HAUTS SARTS, 4EME AVENUE 5 |
HERSTAL,
BE
4040
|
|
Correspondent Contact |
JEAN-YVES MIGNOLET |
Regulation Number | 882.5891
|
Classification Product Code |
|
Date Received | 02/01/2016 |
Decision Date | 03/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|