Device Classification Name |
colonoscope and accessories, flexible/rigid
|
510(k) Number |
K141286 |
Device Name |
AER-O-SCOPE COLONOSCOPE SYSTEM |
Applicant |
GI VIEW LTD. |
901 NEW YORK AVENUE, N.W |
WASHINGTON D.C,
DC
20001
|
|
Applicant Contact |
MARK HELLER |
Correspondent |
GI VIEW LTD. |
901 NEW YORK AVENUE, N.W |
WASHINGTON D.C,
DC
20001
|
|
Correspondent Contact |
MARK HELLER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/16/2014 |
Decision Date | 09/30/2014 |
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
|
|
|