Device Classification Name |
uroflowmeter
|
510(k) Number |
K945495 |
Device Name |
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION |
Applicant |
FIBEROPTIC SENSOR TECHNLOGIES, INC. |
501 AVIS DR. |
ANN ARBOR,
MI
48108
|
|
Applicant Contact |
GARY C SIMPSON |
Correspondent |
FIBEROPTIC SENSOR TECHNLOGIES, INC. |
501 AVIS DR. |
ANN ARBOR,
MI
48108
|
|
Correspondent Contact |
GARY C SIMPSON |
Regulation Number | 876.1800
|
Classification Product Code |
|
Date Received | 11/08/1994 |
Decision Date | 02/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|