Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K820066 |
Device Name |
ELECTROENCEPHALOGRAPHS EEG-5208,5210 |
Applicant |
NIHON KOHDEN AMERICA, INC. |
90 ICON ST. |
FOOTHILL RANCH,
CA
92610 -1601
|
|
Correspondent |
NIHON KOHDEN AMERICA, INC. |
90 ICON ST. |
FOOTHILL RANCH,
CA
92610 -1601
|
|
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 01/11/1982 |
Decision Date | 02/04/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|