Device Classification Name |
Non-Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K982351 |
Device Name |
LUNA |
Applicant |
STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 505 |
WESTMOUNT, QUEBEC, |
CANADA, H32 2N2,
CA
|
|
Applicant Contact |
GEORGE PAPAGIANNIS |
Correspondent |
STELLATE SYSTEMS |
345 VICTORIA AVE., SUITE 505 |
WESTMOUNT, QUEBEC, |
CANADA, H32 2N2,
CA
|
|
Correspondent Contact |
GEORGE PAPAGIANNIS |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/06/1998 |
Decision Date | 07/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|