Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K930578 |
Device Name |
AT33 EMG |
Applicant |
AUTOJECT SYSTEMS, INC. |
OAKWOOD CENTRE |
620 WHEAT LANE |
OAK DALE,
IL
60191
|
|
Applicant Contact |
SAID EL-DINARY |
Correspondent |
AUTOJECT SYSTEMS, INC. |
OAKWOOD CENTRE |
620 WHEAT LANE |
OAK DALE,
IL
60191
|
|
Correspondent Contact |
SAID EL-DINARY |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 02/04/1993 |
Decision Date | 05/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|