Device Classification Name |
electrode, ph, stomach
|
510(k) Number |
K862727 |
Device Name |
ZINETICS GASTROMETER (TM) |
Applicant |
ZINETICS MEDICAL TECHNOLOGY CORP. |
2212 SOUTH WEST TEMPLE, #48 |
SALT LAKE CITY,
UT
84115
|
|
Applicant Contact |
RUSSELL G CARD |
Correspondent |
ZINETICS MEDICAL TECHNOLOGY CORP. |
2212 SOUTH WEST TEMPLE, #48 |
SALT LAKE CITY,
UT
84115
|
|
Correspondent Contact |
RUSSELL G CARD |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 07/18/1986 |
Decision Date | 11/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|