Device Classification Name |
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
|
510(k) Number |
K945120 |
FOIA Releasable 510(k) |
K945120
|
Device Name |
THYMATRON 2000 ELECTROCONVULSIVE SYSTEM |
Applicant |
SOMATICS, INC. |
910 SHERWOOD DR., UNIT 17 |
LAKE BLUFF,
IL
60044
|
|
Applicant Contact |
RICHARD ABRAMS |
Correspondent |
SOMATICS, INC. |
910 SHERWOOD DR., UNIT 17 |
LAKE BLUFF,
IL
60044
|
|
Correspondent Contact |
RICHARD ABRAMS |
Regulation Number | 882.5940
|
Classification Product Code |
|
Date Received | 10/19/1994 |
Decision Date | 10/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|