Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K113771 |
Device Name |
SIGNAL GEAR URETHRAL CATHETER 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 | 876.1620
|
Classification Product Code |
|
Date Received | 12/22/2011 |
Decision Date | 12/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|