Device Classification Name |
Reduced- Montage Standard Electroencephalograph
|
510(k) Number |
K183529 |
Device Name |
AE-120A EEG Head Set |
Applicant |
Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuku-ku |
Tokyo,
JP
161-8560
|
|
Applicant Contact |
Tom Bento |
Correspondent |
NJK & Associates, Inc. |
13721 Via Tres Vista |
San Diego,
CA
92129
|
|
Correspondent Contact |
Natalie Kennel |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/2018 |
Decision Date | 03/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|