Device Classification Name |
electrode, ph, stomach
|
510(k) Number |
K881706 |
Device Name |
PROXIMA 1 PH MONITOR |
Applicant |
TECHNOMANAGEMENT, INC. C/O C.G. |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
CONSTANCE G BUNDY |
Correspondent |
TECHNOMANAGEMENT, INC. C/O C.G. |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
CONSTANCE G BUNDY |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 04/19/1988 |
Decision Date | 07/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|