Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K893475 |
Device Name |
UROVIEW II |
Applicant |
OEC-DIASONICS, INC. |
2341 SOUTH 2300 WEST |
P.O. BOX 25296 |
salt lake city,
UT
84119
|
|
Applicant Contact |
john w tolhurst |
Correspondent |
OEC-DIASONICS, INC. |
2341 SOUTH 2300 WEST |
P.O. BOX 25296 |
salt lake city,
UT
84119
|
|
Correspondent Contact |
john w tolhurst |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 05/04/1989 |
Decision Date | 08/10/1989 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|