Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K080809 |
Device Name |
IEC MEDSIGHT AND MEDBRIGHT |
Applicant |
INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
731-733 SHOTGUN RD. |
FT. LAUDERDALE,
FL
33326
|
|
Applicant Contact |
GERALD GOIFITZER |
Correspondent |
INNOVATIVE ENDOSCOPY COMPONENTS, LLC. |
731-733 SHOTGUN RD. |
FT. LAUDERDALE,
FL
33326
|
|
Correspondent Contact |
GERALD GOIFITZER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/21/2008 |
Decision Date | 08/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|