Device Classification Name |
stimulator, electrical, evoked response
|
510(k) Number |
K894560 |
Device Name |
QSI 9000 |
Applicant |
QUANTIFIED SIGNAL IMAGING, INC. |
290 YORKLAND BLVD. |
TORONTO,
CA
M2J 1R5
|
|
Applicant Contact |
KALNAY, C.A. |
Correspondent |
QUANTIFIED SIGNAL IMAGING, INC. |
290 YORKLAND BLVD. |
TORONTO,
CA
M2J 1R5
|
|
Correspondent Contact |
KALNAY, C.A. |
Regulation Number | 882.1870
|
Classification Product Code |
|
Date Received | 07/20/1989 |
Decision Date | 08/08/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|