Device Classification Name |
Stimulator, Electro-Acupuncture
|
510(k) Number |
K050123 |
Device Name |
P-STIM SYSTEM |
Applicant |
NEUROSCIENCE THERAPY CORP. |
135 LAKE STREET SOUTH |
SUITE 100 |
KIRKLAND,
WA
98033
|
|
Applicant Contact |
JAN MCCOMB |
Correspondent |
NEUROSCIENCE THERAPY CORP. |
135 LAKE STREET SOUTH |
SUITE 100 |
KIRKLAND,
WA
98033
|
|
Correspondent Contact |
JAN MCCOMB |
Classification Product Code |
|
Date Received | 01/19/2005 |
Decision Date | 03/30/2006 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|