Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K851031 |
Device Name |
EXPOSCOP MOBILE IMAGING SYSTEM |
Applicant |
EURO-ELECTRONICS, INC. |
16494 NE 27TH. PLACE |
MIAMI,
FL
33160
|
|
Applicant Contact |
KENNETH J FINCK |
Correspondent |
EURO-ELECTRONICS, INC. |
16494 NE 27TH. PLACE |
MIAMI,
FL
33160
|
|
Correspondent Contact |
KENNETH J FINCK |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 03/12/1985 |
Decision Date | 05/28/1985 |
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
|
|
|