Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K921682 |
Device Name |
ZINETICS AMC |
Applicant |
ZINETICS MEDICAL, INC. |
FORTY-EIGHT TEMPEST PARK |
2212 SOUTH WEST TEMPLE |
SALT LAKE CITY,
UT
84115
|
|
Applicant Contact |
RICHARD VINCINS |
Correspondent |
ZINETICS MEDICAL, INC. |
FORTY-EIGHT TEMPEST PARK |
2212 SOUTH WEST TEMPLE |
SALT LAKE CITY,
UT
84115
|
|
Correspondent Contact |
RICHARD VINCINS |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 04/08/1992 |
Decision Date | 12/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|