Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K823146 |
Device Name |
CALMSET 3 TM |
Applicant |
THOUGHT TECHNOLOGY LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
THOUGHT TECHNOLOGY LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 10/25/1982 |
Decision Date | 12/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|