Device Classification Name |
electrode, ph, stomach
|
510(k) Number |
K902366 |
Device Name |
MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT |
Applicant |
SYNECTICS-DANTEC |
1425 GREENWAY DR. |
SUITE 600 |
IRVING,
TX
75038
|
|
Applicant Contact |
ANNA PETTERSSON |
Correspondent |
SYNECTICS-DANTEC |
1425 GREENWAY DR. |
SUITE 600 |
IRVING,
TX
75038
|
|
Correspondent Contact |
ANNA PETTERSSON |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 05/16/1990 |
Decision Date | 06/08/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|