Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K900170 |
Device Name |
MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U |
Applicant |
ELSCINT, INC. |
3550 SALT CREEK LN, STE. 105 |
ARLINGTON HEIGHTS,
IL
60005
|
|
Applicant Contact |
ROCHELLE M SOBEL |
Correspondent |
ELSCINT, INC. |
3550 SALT CREEK LN, STE. 105 |
ARLINGTON HEIGHTS,
IL
60005
|
|
Correspondent Contact |
ROCHELLE M SOBEL |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 01/12/1990 |
Decision Date | 07/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|