Device Classification Name |
Monitor, Esophageal Motility, Anorectal Motility, And Tube
|
510(k) Number |
K941801 |
Device Name |
ANALGRAPH |
Applicant |
SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. |
LITTLETON,
CO
80120 -4535
|
|
Applicant Contact |
LINDA L DIEDERICH |
Correspondent |
SANDHILL SCIENTIFIC, INC. |
1501-N WEST CAMPUS DR. |
LITTLETON,
CO
80120 -4535
|
|
Correspondent Contact |
LINDA L DIEDERICH |
Regulation Number | 876.1725
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/12/1994 |
Decision Date | 09/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|