Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K943623 |
Device Name |
PQ5000 CT SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
35325 VOKES DR. |
EASTLAKE,
OH
44094
|
|
Applicant Contact |
ROBERT L TUROCY |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
35325 VOKES DR. |
EASTLAKE,
OH
44094
|
|
Correspondent Contact |
ROBERT L TUROCY |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/26/1994 |
Decision Date | 04/27/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|