Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K910371 |
Device Name |
URODYNAMIC MEASURING SYSTEM |
Applicant |
BROWNE MEDICAL SYSTEMS, INC. |
8990 SPRINGBROOK DRIVE, |
SUITE 120 |
MINNEAPOLIS,
MN
55433
|
|
Applicant Contact |
DEBORAH HALL |
Correspondent |
BROWNE MEDICAL SYSTEMS, INC. |
8990 SPRINGBROOK DRIVE, |
SUITE 120 |
MINNEAPOLIS,
MN
55433
|
|
Correspondent Contact |
DEBORAH HALL |
Regulation Number | 876.1620 |
Classification Product Code |
|
Date Received | 01/29/1991 |
Decision Date | 05/15/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|