Device Classification Name |
Uroflowmeter
|
510(k) Number |
K873695 |
Device Name |
MODEL 1859 TUMI/PRESSURE MODULE |
Applicant |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Applicant Contact |
COATS, M.D. |
Correspondent |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Correspondent Contact |
COATS, M.D. |
Regulation Number | 876.1800
|
Classification Product Code |
|
Date Received | 09/14/1987 |
Decision Date | 01/27/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|