Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K983072 |
Device Name |
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 |
Applicant |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Applicant Contact |
GARY REASONER |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
2601 CAMPUS DR. |
IRVINE,
CA
92612 -1601
|
|
Correspondent Contact |
GARY REASONER |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/02/1998 |
Decision Date | 12/01/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|