Device Classification Name |
electrode, ph, stomach
|
510(k) Number |
K872929 |
Device Name |
PH MONITORING SYSTEM |
Applicant |
SENSATRONIX MEDICAL SYSTEMS, INC. |
P.O. BOX 376 |
SO. PLAINFIELD,
NJ
07080
|
|
Applicant Contact |
ALBERTO VELEZ |
Correspondent |
SENSATRONIX MEDICAL SYSTEMS, INC. |
P.O. BOX 376 |
SO. PLAINFIELD,
NJ
07080
|
|
Correspondent Contact |
ALBERTO VELEZ |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 07/27/1987 |
Decision Date | 08/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|