Device Classification Name |
device, biofeedback
|
510(k) Number |
K010388 |
Device Name |
SONDREX P.A.L. SYSTEM |
Applicant |
OHMEDA MEDICAL |
8880 GORMAN RD. |
LAUREL,
MD
20723
|
|
Applicant Contact |
ALBERTO F PROFUMO |
Correspondent |
OHMEDA MEDICAL |
8880 GORMAN RD. |
LAUREL,
MD
20723
|
|
Correspondent Contact |
ALBERTO F PROFUMO |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 02/08/2001 |
Decision Date | 12/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|