Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K011204 |
Device Name |
NEUROFAX, MODELS EEG-1100A, EEG-9100A |
Applicant |
NIHON KOHDEN AMERICA, INC. |
90 ICON ST. |
FOOTHILL RANCH,
CA
92610 -1601
|
|
Applicant Contact |
BONNIE BISHOP |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
90 ICON ST. |
FOOTHILL RANCH,
CA
92610 -1601
|
|
Correspondent Contact |
BONNIE BISHOP |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/19/2001 |
Decision Date | 05/08/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|