Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K992362 |
Device Name |
FLEXISCOPE IQ 101 |
Applicant |
SCHOELLY FIBEROPTIC, GMBH |
45 PONTIAC RD. |
NEWTON,
MA
02248
|
|
Applicant Contact |
JOSEPH RESS |
Correspondent |
SCHOELLY FIBEROPTIC, GMBH |
45 PONTIAC RD. |
NEWTON,
MA
02248
|
|
Correspondent Contact |
JOSEPH RESS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/15/1999 |
Decision Date | 08/05/1999 |
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
|
|
|