Device Classification Name |
device, biofeedback
|
510(k) Number |
K881164 |
Device Name |
LEUNOMED RFB 5000 |
Applicant |
HEMODYNAMICS, INC. |
5301 NORTH FEDERAL HGWY. |
STE. 140 |
BOCA RATON,
FL
33431
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
HEMODYNAMICS, INC. |
5301 NORTH FEDERAL HGWY. |
STE. 140 |
BOCA RATON,
FL
33431
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 03/18/1988 |
Decision Date | 04/24/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|