Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K834503 |
Device Name |
PROFILE URODYNAMIC MONITORING SYS |
Applicant |
BROWNE MEDICAL, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BROWNE MEDICAL, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 12/21/1983 |
Decision Date | 02/21/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|