Device Classification Name |
Monitor, Esophageal Motility, Anorectal Motility, And Tube
|
510(k) Number |
K884527 |
Device Name |
ZINETICS(R) EMC |
Applicant |
ZINETICS MEDICAL, INC. |
FORTY-EIGHT TEMPEST PARK |
2212 SOUTH WEST TEMPLE |
SALT LAKE CITY,
UT
84115
|
|
Applicant Contact |
RUSS GARRISON |
Correspondent |
ZINETICS MEDICAL, INC. |
FORTY-EIGHT TEMPEST PARK |
2212 SOUTH WEST TEMPLE |
SALT LAKE CITY,
UT
84115
|
|
Correspondent Contact |
RUSS GARRISON |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 10/27/1988 |
Decision Date | 02/28/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|