Device Classification Name |
Standard Polysomnograph With Electroencephalograph
|
510(k) Number |
K992742 |
Device Name |
NEUROFAX, MODEL EEG-1100A |
Applicant |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Applicant Contact |
BONNIE BISHOP |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Correspondent Contact |
BONNIE BISHOP |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/16/1999 |
Decision Date | 10/14/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|