Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K944678 |
Device Name |
NIHON KOHDEN ELECTROENCEPHALOGRAPH |
Applicant |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Applicant Contact |
PENNI L PANNELL |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Correspondent Contact |
PENNI L PANNELL |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 09/22/1994 |
Decision Date | 05/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|