Device Classification Name |
amplitude-integrated electroencephalograph
|
510(k) Number |
K163644 |
Device Name |
Nihon Kohden QP-160AK EEG Trend Program |
Applicant |
Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuku-Ku |
Tokyo,
JP
161-8560
|
|
Applicant Contact |
Tom Bento |
Correspondent |
Nihon Kohden America, Inc. |
15353 Barranca Parkway |
Irvine,
CA
92618
|
|
Correspondent Contact |
Tom Bento |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2016 |
Decision Date | 05/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|