Device Classification Name |
electrode, ph, stomach
|
510(k) Number |
K911825 |
Device Name |
TRIP(TM) NASOGASTRIC SUMP CATHETER |
Applicant |
TONOMETRICS, INC. |
4903 SANGAMORE RD. |
BETHESDA,
MD
20816
|
|
Applicant Contact |
DONALD L MACKEEN |
Correspondent |
TONOMETRICS, INC. |
4903 SANGAMORE RD. |
BETHESDA,
MD
20816
|
|
Correspondent Contact |
DONALD L MACKEEN |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 04/24/1991 |
Decision Date | 07/23/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|