Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K905154 |
Device Name |
GASTROSCAN |
Applicant |
MEDICS INSTRUMENT CORP. |
FRIEDHOFPLATZ 16, POB 706 |
CH-4502 |
SOLOTHURN, SWITZERLAND,
SE
|
|
Applicant Contact |
JOHN MATHERLY |
Correspondent |
MEDICS INSTRUMENT CORP. |
FRIEDHOFPLATZ 16, POB 706 |
CH-4502 |
SOLOTHURN, SWITZERLAND,
SE
|
|
Correspondent Contact |
JOHN MATHERLY |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 11/15/1990 |
Decision Date | 06/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|