Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K033677 |
Device Name |
BRAIN PERFUSION OPTION |
Applicant |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER ROAD |
HIGHLAND HTS.,
OH
44143
|
|
Applicant Contact |
ROBERT L TUROCY |
Correspondent |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
595 MINER ROAD |
HIGHLAND HTS.,
OH
44143
|
|
Correspondent Contact |
ROBERT L TUROCY |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 11/24/2003 |
Decision Date | 02/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|