Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K012232 |
Device Name |
INSIGHT, MODEL S980000 |
Applicant |
SANDHILL SCIENTIFIC, INC. |
4655 KIRKWOOD CT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS WARD |
Correspondent |
SANDHILL SCIENTIFIC, INC. |
4655 KIRKWOOD CT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 07/16/2001 |
Decision Date | 06/07/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|