Device Classification Name |
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
|
510(k) Number |
K843441 |
Device Name |
URINARY DRAINAGE CONTAINER 2012-WITH |
Applicant |
VITALMETRICS, INC. |
6341 NANCY RIDGE DRIVE |
SAN DIEGO ,
CA
92121 -
|
|
Applicant Contact |
ANNE WISTER |
Correspondent |
VITALMETRICS, INC. |
6341 NANCY RIDGE DRIVE |
SAN DIEGO ,
CA
92121 -
|
|
Correspondent Contact |
ANNE WISTER |
Regulation Number | 876.1800
|
Classification Product Code |
|
Date Received | 09/04/1984 |
Decision Date | 01/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|