Device Classification Name |
monitor, esophageal motility, anorectal motility, and tube
|
510(k) Number |
K961056 |
Device Name |
BIOVIEW MODEL S960000 |
Applicant |
SANDHILL SCIENTIFIC, INC. |
8955 SOUTH RIDGELINE BLVD., |
UNIT #500 |
HIGHLANDS RANCH,
CO
80126
|
|
Applicant Contact |
LINDA DIEDERICH |
Correspondent |
SANDHILL SCIENTIFIC, INC. |
8955 SOUTH RIDGELINE BLVD., |
UNIT #500 |
HIGHLANDS RANCH,
CO
80126
|
|
Correspondent Contact |
LINDA DIEDERICH |
Regulation Number | 876.1725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/1996 |
Decision Date | 06/06/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|