Device Classification Name |
device, biofeedback
|
510(k) Number |
K971400 |
Device Name |
MUSCLE RESPONSE MONITOR |
Applicant |
ENRICHING YOUR LIFE |
6339 KELLY DR. |
GRANBURY,
TX
76048
|
|
Applicant Contact |
MARY LOU WILSON |
Correspondent |
ENRICHING YOUR LIFE |
6339 KELLY DR. |
GRANBURY,
TX
76048
|
|
Correspondent Contact |
MARY LOU WILSON |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 04/15/1997 |
Decision Date | 04/14/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|