Device Classification Name |
device, biofeedback
|
510(k) Number |
K860271 |
Device Name |
BIOFEEDBACK MICROLAB |
Applicant |
HRM SOFTWARE/DIV. OF HUMAN RELATIONS MEDIA |
175 TOMPKINS AVE. |
PLEASANTVILLE,
NY
10570
|
|
Applicant Contact |
PETER COCHRAN |
Correspondent |
HRM SOFTWARE/DIV. OF HUMAN RELATIONS MEDIA |
175 TOMPKINS AVE. |
PLEASANTVILLE,
NY
10570
|
|
Correspondent Contact |
PETER COCHRAN |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 01/27/1986 |
Decision Date | 06/18/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|