Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K905373 |
Device Name |
MINIATURE TEMPERATURE TRAINER MODEL DT-002 |
Applicant |
BIO-FEEDBACK SYSTEMS, INC. |
2736 47TH ST. |
BOULDER,
CO
80301
|
|
Correspondent |
BIO-FEEDBACK SYSTEMS, INC. |
2736 47TH ST. |
BOULDER,
CO
80301
|
|
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 11/29/1990 |
Decision Date | 04/10/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|