Device Classification Name |
electroconvulsive therapy device for catatonia, major depressive disorder, and bipolar disorder
|
510(k) Number |
K843923 |
FOIA Releasable 510(k) |
K843923
|
Device Name |
THYMATRON |
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 | 10/05/1984 |
Decision Date | 12/03/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|