Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K083577 |
Device Name |
HARMONIE SYSTEM |
Applicant |
STELLATE SYSTEMS |
376 VICTORIA AVENUE, SUITE 200 |
MONTREAL, QUEBEC,
CA
H3Z 1C3
|
|
Applicant Contact |
GOLDY SINGH |
Correspondent |
STELLATE SYSTEMS |
376 VICTORIA AVENUE, SUITE 200 |
MONTREAL, QUEBEC,
CA
H3Z 1C3
|
|
Correspondent Contact |
GOLDY SINGH |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 12/03/2008 |
Decision Date | 08/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|