Device Classification Name |
Stimulator, Electrical, Evoked Response
|
510(k) Number |
K051178 |
Device Name |
MEE-1000A NEUROMASTER |
Applicant |
NIHON KOHDEN AMERICA, INC. |
90 ICON ST. |
FOOTHILL RANCH,
CA
92610 -1601
|
|
Applicant Contact |
SERRAH NAMINI |
Correspondent |
NIHON KOHDEN AMERICA, INC. |
90 ICON ST. |
FOOTHILL RANCH,
CA
92610 -1601
|
|
Correspondent Contact |
SERRAH NAMINI |
Regulation Number | 882.1870
|
Classification Product Code |
|
Date Received | 05/09/2005 |
Decision Date | 08/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|