Device Classification Name |
Light Source, Endoscope, Xenon Arc
|
510(k) Number |
K905124 |
Device Name |
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE |
Applicant |
RED WING IMAGING, INC. |
18 R. F. HIGGINS DR. |
NORWELL,
MA
02061
|
|
Applicant Contact |
ROBERT L KANE |
Correspondent |
RED WING IMAGING, INC. |
18 R. F. HIGGINS DR. |
NORWELL,
MA
02061
|
|
Correspondent Contact |
ROBERT L KANE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/14/1990 |
Decision Date | 01/25/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|