Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K091070 |
Device Name |
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM |
Applicant |
SIERRA SCIENTIFIC INSTRUMENTS, INC. |
5757 CENTURY BLVD. |
SUITE 660 |
LOS ANGELES,
CA
90045
|
|
Applicant Contact |
REIC S FINKELMAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 04/14/2009 |
Decision Date | 05/19/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|