Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K060166 |
Device Name |
OHMEGA |
Applicant |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 |
ENSCHEDE,
NL
7521 PV
|
|
Applicant Contact |
K. OGINK-SOMHORST |
Correspondent |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
COLOSSEUM 25 |
ENSCHEDE,
NL
7521 PV
|
|
Correspondent Contact |
K. OGINK-SOMHORST |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 01/23/2006 |
Decision Date | 04/21/2006 |
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
|
|
|