Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K882378 |
Device Name |
P-7 COMPUTED TOMOGRAPHY SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Applicant Contact |
WILLIAM J GERBER |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
5500 AVION PARK DR. |
HIGHLAND HEIGHTS,
OH
44143
|
|
Correspondent Contact |
WILLIAM J GERBER |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 06/08/1988 |
Decision Date | 10/11/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|