Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K110138 |
Device Name |
PAIRED HYDROGEL ELECTRODE |
Applicant |
NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 |
VENTURA,
CA
93003
|
|
Applicant Contact |
CHRISTINE VERGELY |
Correspondent |
NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 |
VENTURA,
CA
93003
|
|
Correspondent Contact |
CHRISTINE VERGELY |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 01/18/2011 |
Decision Date | 04/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|