Device Classification Name |
Stimulator, Electro-Acupuncture
|
510(k) Number |
K140788 |
Device Name |
P-STIM |
Applicant |
BIEGLER GMBH |
24301 WOODSAGE DR |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
BIEGLER GMBH |
24301 WOODSAGE DR |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Classification Product Code |
|
Date Received | 03/31/2014 |
Decision Date | 06/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|