|
Device |
endoscopic video imaging system/component, gastroenterology-urology |
Definition |
To allow for visualization of body cavities through an endoscope by projecting images to a monitor. |
Product Code | FET |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
FUJIFILM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM NEW DEVELOPMENT U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJINON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY AMERICA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KARL STORZ ENDOSCOPY-AMERICA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PENTAX OF AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SCHOELLY IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STI MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.O.M. WORLD OF MEDICINE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|